Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
MHRA National Patient Safety Alert: ResMed Astral 100/150 Ventilators Unexpected Ventilation Interruption
2026-08-17 | UK MHRA | Safety Communication | !!! HIGH
This MHRA National Patient Safety Alert (NatPSA/2026/004/MHRA) concerns ResMed Astral 100 and 150 ventilators and associated Printed Circuit Board Assembly spare parts manufactured before October 2024. A device fault can cause unexpected interruption of ventilation therapy, potentially resulting in patient harm. Affected users, caregivers, and healthcare providers should identify affected devices and implement the actions specified in ResMed's Field Safety Notice and the MHRA alert.
Tags: mhra, resmed_astral, ventilator, field_safety_notice, patient_safety
MHRA Publishes Suspended and Revoked Licences for Medicines Manufacturers and Wholesalers
2026-08-17 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has updated its public list of companies whose licences or registrations to manufacture or wholesale medicines and active ingredients have been suspended or revoked. The list affects manufacturers, wholesalers, and trading partners in the UK medicines supply chain. Regulatory affairs and quality professionals should check the current list to verify the compliance status of suppliers, contract manufacturers, and distributors, and take immediate action if a partner appears on the list.
Tags: uk_mhra, medicine_licensing, enforcement
NMPA Publishes 46 Medical Device Industry Standards (14 August 2026)
2026-08-14 | NMPA | Standard Revision | !!! HIGH
On 14 August 2026 NMPA published 46 medical device industry standards covering biomaterials, life support, implants, biological evaluation and software measurement methods. Two mandatory standards (YY 0055-2026 dentistry powered polymerization activators; YY 1412-2026 extracorporeal cardiopulmonary support) take effect on 1 August 2029. Two recommended standards take effect on 1 February 2028; the remaining 42 recommended standards take effect on 1 August 2027.
Tags: standards, YY, industry_standard, nmpa
MHRA Updates List of Medical Devices Granted Exceptional Use Authorisations
2026-08-14 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA decision provides an updated list of manufacturers and medical devices that have been granted exceptional use authorisations (exemptions) in the UK. It also identifies devices whose exemptions have expired or been cancelled. Regulatory affairs professionals should review the list to confirm the current authorisation status of relevant devices and take action if a product's exemption is no longer active.
Tags: exceptional_use_authorisation, mhra, medical_device_exemption
Health Canada Alert: Performance Concerns with Orthopaedic Implant Components
2026-08-14 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a recall/alert regarding performance issues with orthopaedic implant components. The notice may affect healthcare facilities that stock or use the implicated components and patients who have received them. Regulatory affairs and clinical teams should review the Health Canada alert, identify affected lots, quarantine or return devices as instructed, and follow any patient monitoring or reporting requirements.
Tags: orthopaedic_implants, medical_device_recall, health_canada
Health Canada Recall/Alert: Endotracheal Tube, Cuffed – Device Compatibility
2026-08-14 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for cuffed endotracheal tubes due to a device compatibility concern. The alert affects healthcare facilities and providers that stock or use the affected endotracheal tubes, potentially involving compatibility with other airway devices or accessories. Affected users should identify and quarantine relevant inventory, verify device compatibility according to the manufacturer’s instructions, and follow the actions specified by Health Canada and the manufacturer. Report any related adverse events or product problems to Health Canada.
Tags: medical_device_recall, endotracheal_tube, device_compatibility
HSA Publishes Summary of Responses to Public Consultation Feedback on Medical Device Cybersecurity Best Practices Guide
2026-08-14 | Singapore HSA | Regulation Update | !! MEDIUM
The Health Sciences Authority (HSA) has published a summary of responses to feedback received during the public consultation on its Best Practices Guide for Medical Device Cybersecurity. This item is relevant to medical device manufacturers, importers, and suppliers placing devices in Singapore, as it clarifies stakeholder comments and HSA's positions on cybersecurity expectations. Regulatory affairs professionals should review the responses and the final guide to ensure their medical device cybersecurity documentation and risk management align with HSA recommendations.
Tags: medical_device_cybersecurity, hsa, regulatory_guidance, public_consultation, singapore
Health Canada Recalls IV Tubing Set Drip Chambers Over Performance Issues
2026-08-13 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for IV tubing set drip chambers due to performance issues. Healthcare facilities using affected IV tubing sets should identify and quarantine impacted lots and follow the manufacturer’s recall instructions. Regulatory affairs professionals should monitor Health Canada notices for affected models, lot numbers, and required corrective actions.
Tags: health_canada, medical_device_recall, iv_tubing_set, performance_issue
Health Canada Recall: Portrait Core Services Cssxb – Performance Issue
2026-08-13 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a medical device recall/alert for Portrait Core Services Cssxb due to a performance issue. This notice affects Canadian healthcare facilities and users of the affected product. Review the recall details, identify affected units, and implement the manufacturer's recommended corrective actions promptly.
Tags: medical_device_recall, health_canada, performance_issue
IV Sets or Administration Sets - ICU Medical, Inc.
2026-08-13 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: IV Sets or Administration Sets. Reason: . Model: various.
MHRA Guidance: Notify Clinical Investigations for Medical Devices
2026-08-12 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance explains how sponsors must notify the MHRA of their intention to conduct a clinical investigation for a medical device in the UK. It applies to manufacturers, sponsors, and clinical research organisations planning device studies. Affected parties should review the notification requirements, prepare the necessary documentation, and submit the notification to MHRA before starting the investigation.
Tags: mhra, clinical_investigation, medical_devices, regulatory_guidance
Adequan I.M. Recall: Particulate Matter Contamination in Injectable Product
2026-08-12 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a product quality recall for Adequan I.M. due to the presence of particulate matter in the injectable product. The affected product is used in veterinary settings, and particulate contamination may pose risks such as injection-site reactions or vascular obstruction. Users should immediately quarantine affected lots, stop use, and follow recall return instructions.
Tags: canada_recall, particulate_matter, product_quality
SPECTRALIS with FLex Module - Heidelberg Engineering GmbH
2026-08-12 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Ophthalmology instruments. Reason: . Model: .
Hamilton Medical Recalls Breathing Circuit Set: FDA Announces Removal
2026-08-11 | FDA | cdrh_news | !!! HIGH
The FDA announced that Hamilton Medical is recalling its Breathing Circuit Set. Healthcare facilities using these circuits should immediately stop use and return affected products. The recall addresses a potential issue that could compromise ventilation therapy; specific lot numbers and corrective actions are outlined in the company's notification.
Tags: medical_device_recall, breathing_circuit, hamilton_medical, ventilation, safety_alert
MHRA Field Safety Notices: 3 to 7 August 2026
2026-08-11 | UK MHRA | Safety Communication | !! MEDIUM
This MHRA page lists Field Safety Notices (FSNs) issued for medical devices and drug-device products between 3 and 7 August 2026. The update includes two new entries in the feed. Healthcare providers, medical device manufacturers, and users should review the listed notices and take any recommended actions for affected devices. FSNs may include recalls, safety alerts, or instructions for use changes.
Tags: field_safety_notices, mhra, medical_device_safety
Swissmedic FSCA: Alber e-motion M25 Wheelchair Propulsion System – Added Language
2026-08-11 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic FSCA covers the e-motion M25 wheelchair electric-motor-driven propulsion system from Alber GmbH. The corrective action was issued because a new language has been added to the device documentation/labeling. The affected model is M25. Responsible parties should update and distribute the new language version according to Swissmedic requirements.
Tags: swissmedic_fsca, labeling_update, wheelchair_propulsion
Bravo CF capsule delivery dev - Given Imaging Inc.
2026-08-11 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Gastrointestinal telemetric monitoring system. Reason: additional languages added. Model: FGS-0635, FGS-0636.
EPIQ Ultrasound System - Philips Medical Systems Nederland B.V.
2026-08-11 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: General-purpose ultrasound imaging system. Reason: . Model: 795234.
Healon Duet - AMO Uppsala AB
2026-08-11 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Ophthalmology, hyaluronic acid and derivatives. Reason: . Model: 10301016.
Swissmedic FSCA: Healon EndoCoat by AMO Uppsala AB, Model 10301012
2026-08-11 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for Healon EndoCoat, manufactured by AMO Uppsala AB, an intraoperative vitreous/aqueous humour replacement medium, covering model 10301012. The specific reason for the corrective action is not detailed in the brief alert summary; regulatory affairs professionals should review the full Swissmedic FSCA notice for detailed reason and required actions. Users with affected product should verify inventory and follow the manufacturer’s field safety notice.
Tags: swissmedic, fsca, ophthalmic_device
Swissmedic FSCA: Edwards Lifesciences ForeSight Oximeter Cable for Bedside Monitors
2026-08-11 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a field safety corrective action (FSCA) concerning the Edwards Lifesciences ForeSight Oximeter Cable, which is used with general-purpose multi-parameter bedside monitors. The specific reason and affected model/lot are referenced in the manufacturer’s Field Safety Notice (FSN). Users should review the FSN and follow the manufacturer’s recommended corrective actions.
Tags: swissmedic, fsca, medical_device, oximeter_cable, field_safety_corrective_action
Philips Azurion Angiographic X-Ray System: Swissmedic FSCA for Multiple Models
2026-08-11 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic field safety corrective action (FSCA) concerns the Philips Azurion stationary angiographic X-ray system, manufactured by Philips Medical Systems Nederland B.V. The affected models include 722063, 722064, 722067, 722068, 722078, 722079, 722221 through 722228, and 722280. The provided notice does not specify the reason for the corrective action, so regulatory affairs professionals and affected users should consult the official Swissmedic FSCA and Philips instructions for required actions.
Tags: swissmedic, fsca, medical_device_safety
MHRA Safety Alert: Medical Devices Supplied Without UKCA/CE Markings Must Be Removed and Quarantined
2026-08-10 | UK MHRA | Safety Communication | !!! HIGH
The MHRA has identified a number of medical devices on the UK market that lack valid UKCA or CE conformity markings and the required certification, breaching the UK Medical Devices Regulations 2002. Healthcare providers, importers, and distributors must immediately remove these non-compliant devices from use, place them in quarantine, and ensure they are not further distributed. The alert warns that failure to act may result in enforcement action and reiterates the need to verify conformity documentation before supply.
Tags: uk_mhra, safety_alert, non_compliant_device
MHRA advises quarantine of medical devices supplied without appropriate conformity markings
2026-08-10 | UK MHRA | Regulation Update | !!! HIGH
The MHRA has issued an advisory for economic operators to quarantine medical devices found on the UK market that lack required conformity markings under UK MDR 2002 or EU MDR 2017/745. Such devices may not meet essential safety and performance standards, posing risks to patients and users. The agency urges immediate inspection of stock and supply chains, and reporting of non-compliant products to the MHRA.
Tags: mhra_advisory, conformity_marking, quarantine_notice
MHRA: Remove from use and quarantine devices lacking valid UKCA/CE conformity markings or certification (DSI/2026/007)
2026-08-10 | UK MHRA | Regulation Update | !!! HIGH
The MHRA has identified medical devices being supplied on the UK market without valid UKCA or CE conformity markings or proper certification, breaching UK MDR 2002 and EU MDR 2017/745. Healthcare providers and suppliers are required to immediately remove these non-compliant devices from use and place them in quarantine. The devices must not be used or supplied until compliance is verified, and all incidents should be reported to the MHRA.
Tags: ukca_marking, ce_marking, non_compliance, quarantine, mhra_alert, medical_device_regulation
ANMAT Prohibits One Unit of FotoFinder Dermatoscope (Aug 10, 2026)
2026-08-10 | Argentina ANMAT | Safety Communication | !!! HIGH
On August 10, 2026, Argentina's ANMAT issued an alert prohibiting one unit of the FotoFinder brand dermatoscope. The prohibition is unit-specific and based on safety concerns identified in the official ANMAT notice. Affected users and distributors should identify the prohibited unit, remove it from use, and follow ANMAT instructions.
Tags: argentina_anmat, dermatoscope, product_ban, medical_device_safety
Health Canada Recalls Bravo Capsule Delivery System Over Performance Issues
2026-08-07 | Health Canada | Safety Communication | !! MEDIUM
Health Canada has issued a recall for the Bravo Capsule Delivery System due to performance concerns. This device is used for esophageal pH monitoring in patients with gastroesophageal reflux disease. The performance issue may cause the capsule to detach prematurely or fail to deploy accurately, potentially leading to unreliable diagnostic data or patient discomfort. Healthcare facilities should immediately identify and quarantine affected lots, discontinue use, and follow the manufacturer's return instructions.
Tags: medical_device_recall, performance_issue, ph_monitoring
Swissmedic FSCA: ORBIS Medication 3.x – DH Healthcare GmbH
2026-08-07 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for ORBIS Medication 3.x, a medical device software from DH Healthcare GmbH. The action addresses a potential safety issue related to medication management. Affected users should consult the manufacturer’s notice for required measures, which may include software updates or workarounds, to ensure safe use.
Tags: swissmedic, fsca, medical_device_software, medication_safety, dh_healthcare
Swissmedic FSCA: GXD5 PACS by ENOVACOM – Field Safety Corrective Action for PACS
2026-08-07 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the GXD5 Picture Archiving and Communication System (PACS) from ENOVACOM. The specific reason for the corrective action and affected models were not provided in the notification. Users of this device should check the official Swissmedic FSCA page and contact the manufacturer for detailed instructions and required actions.
Tags: swissmedic, fsca, pacs, medical_device, safety_notice
Field Safety Corrective Action for medin Medical Innovations NC3 Neonatal CPAP Unit
2026-08-07 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the medin Medical Innovations GmbH neonatal CPAP unit, models NC3 and 3000. The action addresses a potential safety issue with the device. Healthcare facilities using these models should immediately follow the manufacturer's corrective instructions to mitigate risks and ensure continued safe use.
Tags: fsca, neonatal_cpap, swissmedic, field_safety_corrective_action, medin_medical_innovations, nc3, 3000, patient_safety
Belzer UW® Cold Storage Solution and Belzer MPS® (UW Machine Perfusion Solution): manufactured by Carnamedica (UKRP: Bri
2026-08-06 | UK MHRA | Safety Communication | !! MEDIUM
The MHRA is providing an update on defects previously identified with Belzer solutions for the preservation of donated organs. This DSI replaces advice in DSI/2023/005.
MHRA Guidance: Compiling a Submission for Clinical Investigations of Medical Devices
2026-08-06 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has released guidance detailing how sponsors should compile and submit notifications for clinical investigations of medical devices. It outlines the required documentation, format, and procedure, enabling manufacturers and sponsors to prepare complete applications and avoid delays. This guidance is crucial for anyone planning a clinical study in the UK.
Tags: clinical_investigation, mhra_guidance, submission_process
Beckman Coulter AU480 Analyzer Recalled in Canada Due to Performance Issues
2026-08-06 | Health Canada | Safety Communication | !! MEDIUM
Health Canada has issued a recall for the Beckman Coulter AU Immunochemistry System AU480 Analyzer due to performance concerns. The device may produce inaccurate test results, potentially affecting patient diagnosis and management. All users should immediately review the recall notice, verify instrument performance according to Beckman Coulter's instructions, and contact the manufacturer for corrective actions. The recall requires healthcare facilities to identify affected units and implement mitigation measures to ensure result reliability.
Tags: medical_device_recall, in_vitro_diagnostics, performance_issue
Health Canada Recalls HEALON EndoCoat PRO Due to Performance Issue
2026-08-06 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall alert for HEALON EndoCoat PRO, an ophthalmic viscosurgical device, due to a performance deficiency that may compromise device functionality and patient safety. Affected healthcare facilities are required to immediately stop using the identified lots, quarantine the products, and follow the manufacturer’s return instructions. This action is part of routine medical device safety monitoring.
Tags: recall, performance_issue, health_canada
One Lot of New Roots Herbal Probiotic Intensity Recalled Due to Incorrect 'No Dairy' Claim
2026-08-06 | Health Canada | Safety Communication | !! MEDIUM
Health Canada has recalled one lot of New Roots Herbal Probiotic Intensity because the label incorrectly states 'No Dairy.' The product may contain milk protein, posing a risk to those with milk allergy. Consumers should stop using the affected lot immediately and consult a healthcare professional if they experience symptoms. Distributors and retailers must remove the product from sale.
Tags: allergen_labeling, health_product_recall, labeling_compliance
Swissmedic FSCA for Cardioroot Woven Synthetic Vascular Graft by Intervascular SAS
2026-08-06 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Cardioroot Woven, a non-medicated synthetic vascular graft manufactured by Intervascular SAS. The specific reason for the corrective action was not detailed in the public notice. Affected model numbers include HEWROOT0024, HEWROOT0026, HEWROOT0028, HEWROOT0030, HEWROOT0032, and HEWROOT0034. Users should immediately consult the manufacturer’s FSCA notice and follow all recommended actions to ensure patient safety.
Tags: swissmedic, fsca, vascular_graft, intervascular, cardioroot_woven, medical_device_safety
ResMed Astral 100/150 Ventilator Class I Recall: Supercapacitor Leak May Stop Therapy
2026-08-05 | FDA | recall_class1 | !!! HIGH
FDA has classified ResMed’s recall of the Astral 100 and Astral 150 ventilators as a Class I recall, the most serious type, because electrolyte leakage from a supercapacitor on the printed circuit board assembly can damage the charger chip and force the device into a fail-safe state, interrupting ventilation therapy. This failure may cause serious patient harm or death. The recall covers 168,069 units distributed globally. Users must follow ResMed’s instructions to monitor for alarms and contact the company for a replacement if the device is affected.
Tags: class_i_recall, ventilator, resmed, supercapacitor_leakage, patient_safety
Class I Recall of Medical Action Industries Angiography Pack (REF NCAG62I) Due to Particulate in Fluid Path
2026-08-05 | FDA | recall_class1 | !!! HIGH
Medical Action Industries, Inc. has initiated a Class I recall of its Pack Angiography NCMC 3/Cs BANNER (REF NCAG62I) because the included Medline Namic manifolds may contain particulate in the fluid path. If particles enter the bloodstream during cardiovascular procedures, they could cause serious adverse health events. The recall involves 657 kits distributed across the U.S.; healthcare facilities should immediately stop using the affected product, quarantine remaining inventory, and follow return instructions.
Tags: class_i_recall, particulate_contamination, angiography_pack, medical_action_industries, vascular_procedure
Health Canada Recall Alert: FilmArray NGDS Warrior Panel Performance Issue
2026-08-05 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall alert for the FilmArray NGDS Warrior Panel due to a potential performance issue that could lead to inaccurate test results. This affects healthcare facilities and laboratories using the panel for diagnostic testing. Users should immediately discontinue use of affected lots, review the manufacturer’s notice, and contact BioMérieux for further guidance.
Tags: medical_device_recall, performance_issue, diagnostic_test, health_canada, infectious_disease
Health Canada Recalls Med-RX Wound Care Kits Over Sterility Failure
2026-08-05 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for Med-RX Wound Care Kits due to a potential lack of sterility, which may lead to serious infections. Healthcare facilities and patients who have these kits should immediately stop using them and follow the manufacturer's instructions for return or safe disposal. This safety alert is one of multiple recent Canadian medical device recalls involving sterility breaches.
Tags: medical_device_recall, sterility_breach, wound_care, health_canada, infection_risk
Health Canada Issues Recall for 1788 4K Camera Over Performance Concerns
2026-08-05 | Health Canada | Safety Communication | !!! HIGH
Health Canada has released a medical device recall alert for the 1788 4K Camera due to performance issues that may compromise image quality or device reliability during clinical procedures. The recall affects healthcare facilities using this camera system for endoscopic or surgical visualization. Affected users are advised to immediately stop using the device, quarantine affected units, and contact the manufacturer for corrective actions, which may include repair, replacement, or software updates. This alert is part of a broader safety bulletin involving multiple recent Canadian medical device recalls.
Tags: medical_device_recall, performance_issue, 4k_camera, health_canada, imaging_device, surgical_visualization
Class II Recall: Daiichi Ika's Stella FU-STE ENT Treatment Unit (Recall #2-12921)
2026-08-05 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall (No. 2-12921) for the Stella FU-STE ear, nose, and throat (ENT) treatment unit manufactured by Daiichi Ika Co., Ltd. The recall addresses a potential safety issue that may affect device performance and patient safety. Healthcare facilities should immediately stop using the affected device, quarantine it, and contact Daiichi Ika for necessary corrective actions such as repair or replacement.
Tags: japan_pmda, class_ii_recall, ent_device, medical_device_recall, daiichi_ika, stella_fu_ste
Swissmedic FSCA: Hemospray Endoscopic Hemostat (Cook Endoscopy) Models HEMO-7, HEMO-10
2026-08-05 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action for Cook Endoscopy’s Hemospray Endoscopic Hemostat, affecting models HEMO-7 and HEMO-10. The notice covers a non-organic haemostatic agent; the specific reason for the action was not detailed in the FSCA. Affected users should immediately follow the manufacturer’s instructions, which likely include quarantine and return of the devices.
Tags: fsca, endoscopic_hemostat, cook_endoscopy
FSCA for ALPHAMAQUET Electrohydraulic Operating Table Base by MAQUET GmbH (Models 115002B0)
2026-08-05 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the ALPHAMAQUET electrohydraulic operating table base, manufactured by MAQUET GmbH. The affected model is listed as 115002B0 (appears twice). The reason for the corrective action is not specified in the notice, but users are advised to consult the manufacturer's instructions and the FSCA portal for recommended actions. This is a safety-related alert for healthcare facilities using this operating table base.
Tags: fsca, operating_table, swissmedic, maquet, safety_alert
Swissmedic FSCA: MAQUET Electrohydraulic Operating Table Base Model 115002D0
2026-08-05 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for MAQUET GmbH's electrohydraulic operating table base, model 115002D0. The specific safety issue has not been publicly detailed, but affected users must immediately implement the manufacturer's corrective measures to mitigate risk.
Tags: swissmedic, fsca, operating_table, maquet, medical_device
ALPHAMAQUET Operating table column - MAQUET GmbH
2026-08-05 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Electrohydraulic operating table base. Reason: . Model: 115002A0; 115002A0.
Swissmedic FSCA: MAQUET Mobile OR-Table Column (Model 115002C0)
2026-08-05 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action for the MAQUET GmbH mobile electrohydraulic operating table column, model 115002C0. The corrective action addresses a safety issue with the table base. Affected users should immediately follow the manufacturer’s instructions in the FSCA notice and contact MAQUET for further guidance.
Tags: swissmedic, fsca, maquet, operating_table, safety_correction, medical_device
Medline Recalls Convenience Kits with Huons Lidocaine and Bupivacaine Injection Due to Incorrect Drug Concentration
2026-08-04 | FDA | cdrh_news | !!! HIGH
Medline Industries has issued a correction for convenience kits containing Huons Lidocaine Hydrochloride and Bupivacaine Hydrochloride in Dextrose Injection due to a labeling error that misstates the drug concentration. Affected kits were distributed to healthcare facilities nationwide. Users should immediately quarantine and return any impacted kits to Medline and avoid using the product until corrected replacements are provided.
Tags: convenience_kit_recall, lidocaine_bupivacaine, medication_labeling_error, cdrh, medical_device_correction
Medical Action Industries Corrects Convenience Kits with Recalled Namic Manifolds
2026-08-04 | FDA | cdrh_news | !! MEDIUM
Medical Action Industries has issued a correction for certain convenience kits that contain Namic manifolds previously recalled due to potential sterility or performance issues. Healthcare providers and facilities using these kits should immediately identify and quarantine affected products, and follow the company’s instructions for return or replacement. The FDA notice alerts users to check inventory and stop using impacted kit lots to prevent patient safety risks.
Tags: recall, convenience_kit, namic_manifold, correction, sterility_risk
Argon Medical Issues Correction for Convenience Kits Containing Spectra Lidocaine Ampules
2026-08-04 | FDA | cdrh_news | !! MEDIUM
Argon Medical has announced a voluntary correction for convenience kits that include Spectra Medical Device Lidocaine Ampules, due to a potential issue with the ampules. Healthcare providers using these kits should immediately quarantine and stop using the affected products, and follow Argon Medical’s instructions for return or disposal. The FDA is sharing this CDRH news update to raise awareness and protect patient safety.
Tags: convenience_kit, argon_medical, lidocaine_ampules, field_correction, cdrh_news
FDA Posts Town Hall Slides & Transcript on Human Factors Info in Marketing Submissions Final Guidance (July 2026)
2026-08-04 | FDA | cdrh_news | !! MEDIUM
The CDRH published the presentation, slides, and transcript from the July 22, 2026 town hall discussing the final guidance on human factors information in medical device marketing submissions. The materials clarify how manufacturers should incorporate usability engineering data in 510(k), PMA, and De Novo applications. Review is recommended for regulatory and R&D teams to align future submissions with current FDA expectations.
Tags: human_factors, marketing_submission, town_hall, final_guidance
MHRA Field Safety Notices: 27 to 31 July 2026 (4 New Notices Published)
2026-08-04 | UK MHRA | Safety Communication | ! LOW
This item lists four field safety notices (FSNs) issued by the UK MHRA between 27 and 31 July 2026. These notices alert healthcare professionals and users to potential safety issues with specific medical devices. Affected parties should review the individual FSNs for details on affected products, risks, and recommended actions. The compilation serves as a weekly roundup for regulatory surveillance.
Tags: field_safety_notice, mhra, medical_device_safety, weekly_summary
Dräger Issues Expanded Field Safety Notice for Atlan Anaesthesia Workstations Ventilator Failure Risk (DSI/2026/005)
2026-08-04 | UK MHRA | Safety Communication | !!! HIGH
In April 2026, Dräger issued a follow-up Field Safety Notice expanding the number of affected Atlan Anaesthesia workstation devices due to a manufacturing defect that may cause mechanical ventilation failure. The MHRA safety alert (DSI/2026/005) advises healthcare providers to immediately identify and quarantine impacted devices, contact Dräger for corrective action, and review previous ventilation failure reports. This update follows an earlier notice and underscores the serious risk of unexpected ventilator shutdown during anaesthesia procedures.
Tags: drager, atlan_anaesthesia_workstation, ventilator_failure
UK MHRA Updates Public List of Suspended/Revoked Manufacturer and Wholesaler Licences (5 New Decisions)
2026-08-04 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has added five new decisions to its public enforcement list of suspended or revoked licences and registrations for manufacturers and wholesalers of medicines and active pharmaceutical ingredients. The list identifies entities no longer authorised to carry out these activities. Regulatory professionals should review the updated list to verify the compliance status of suppliers and partners, and take appropriate supply chain actions.
Tags: uk_mhra, license_suspensions, manufacturing_license, wholesale_license, enforcement, supply_chain_compliance
MHRA Field Safety Notices Summary: 27-31 July 2026
2026-08-04 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has published a roundup of 5 new field safety notices (FSNs) issued between 27 and 31 July 2026, covering medical devices and drug-device combinations. This weekly list alerts healthcare professionals, device suppliers, and users to potential safety issues requiring immediate review. Recipients should identify affected products and follow the specified corrective actions to ensure patient safety and regulatory compliance.
Tags: field_safety_notices, mhra, medical_device_safety, recall_alert, regulatory_compliance
Health Canada Recalls Needle Kit for Powered Driver Due to Performance Issue
2026-08-04 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for a needle kit used with a powered driver because of a performance defect. This issue may compromise the device's intended function and pose risks to patients or users. Affected healthcare facilities and professionals should immediately identify and quarantine the product, and follow the manufacturer’s instructions for corrective action. The alert underscores the need for ongoing performance monitoring of medical devices.
Tags: recall, needle_kit, powered_driver, performance_issue, safety_alert
[Class II] イオム レガロ (歯科用ユニット) - 株式会社ジーシー
2026-08-04 | Japan PMDA | Safety Communication | !! MEDIUM
Recall #2-12920: 歯科用ユニット / イオム レガロ by 株式会社ジーシー. Type: 医療機器.
Class II Recall: Olympus Disposable Ligation Device (Endoscopic Loop Ligator) – PMDA Recall #2-12918
2026-08-04 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall (No. 2-12918) for the Olympus Medical Systems Disposable Ligation Device (Endoscopic Loop Ligator). The recall addresses a potential quality or performance issue that may affect device safety. Healthcare facilities should immediately quarantine affected lots, cease use, and follow Olympus’s return or disposal instructions as detailed in the official recall notice.
Tags: pmda, class_ii_recall, olympus, endoscopic_ligation, disposable_device, medical_device_safety
Swissmedic FSCA for Maquet Cardiopulmonary Vascular Catheter Introduction Set, Model 701047385
2026-08-04 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for the non-implantable vascular catheter introduction set manufactured by Maquet Cardiopulmonary GmbH, specifically model 701047385. The public notice does not detail the reason for the corrective action. Healthcare facilities and professionals should identify affected units and follow the manufacturer's safety instructions without delay.
Tags: swissmedic_fsca, vascular_catheter, maquet_cardiopulmonary, field_safety_corrective_action
Swissmedic FSCA: Maquet Cardiopulmonary GmbH PIK 100-USA Vascular Catheter Introduction Set (Model 701053068)
2026-08-04 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for the PIK 100-USA vascular catheter introduction set, manufactured by Maquet Cardiopulmonary GmbH, affecting model 701053068. The specific reason for the corrective action was not detailed in the initial notice. Users should identify any affected devices in their inventory and follow the manufacturer's instructions for corrective measures.
Tags: fsca, swissmedic, vascular_catheter, maquet, corrective_action
PIK 100 Vascular Catheter Introduction Set: Swissmedic Field Safety Corrective Action
2026-08-04 | Swissmedic | Safety Communication | !!! HIGH
Maquet Cardiopulmonary GmbH has issued a Field Safety Corrective Action (FSCA) for the nonimplantable vascular catheter introduction set model PIK 100 (model 701047384). The specific reason for the corrective action has not been detailed in the Swissmedic notification. Affected users should immediately follow the manufacturer’s instructions and contact Maquet Cardiopulmonary GmbH for necessary guidance and remedial steps.
Tags: swissmedic, fsca, medical_device, catheter_introduction_set, maquet
Swissmedic Issues FSCA for Maquet PIK Dilator Set L (Model 701054427)
2026-08-04 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic published a Field Safety Corrective Action (FSCA) from Maquet Cardiopulmonary GmbH for the PIK dilator set L, a nonimplantable vascular catheter introduction set, model 701054427. The specific reason for the corrective action was not detailed in the notice. Users should consult the manufacturer's communication for required actions to mitigate any potential risk associated with the device.
Tags: swissmedic, fsca, maquet_cardiopulmonary, vascular_catheter_introduction_set, pik_dilator_set
Swissmedic FSCA: PIK dilator S (Model 701054606) by Maquet Cardiopulmonary GmbH
2026-08-04 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the PIK dilator S (model 701054606), a non-implantable vascular catheter introduction set manufactured by Maquet Cardiopulmonary GmbH. The specific reason for the action has not been detailed in the public notice, but affected users should immediately identify and quarantine the device and follow the manufacturer's instructions for corrective measures. This alert applies to the specified model number.
Tags: fsca, vascular_catheter, maquet_cardiopulmonary, swissmedic, device_safety
PIK 150-USA - Maquet Cardiopulmonary GmbH
2026-08-04 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Vascular catheter introduction set, nonimplantable. Reason: . Model: 701053069.
Health Canada Opens Consultation on Proposed Changes to the List of Recognized Standards for Medical Devices
2026-08-03 | Health Canada | Regulation Update | !! MEDIUM
Health Canada has launched a public consultation on proposed updates to the List of Recognized Standards for medical devices. This consultation invites stakeholders to comment on the addition, modification, or removal of specific standards that manufacturers may use to demonstrate compliance with the Medical Devices Regulations. Affected parties include medical device manufacturers, importers, and industry associations. Feedback must be submitted by the specified deadline to influence the final list.
Tags: canada, standards, consultation, regulatory_update, medical_devices
PMDA Class II Recall: Japan Stryker Sterile Trauma Drill Bits (Surgical Drill Bits)
2026-08-03 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12916) for the Sterile Drill Bits for Trauma (surgical drill bits) distributed by Japan Stryker K.K. The recall addresses a potential safety issue that may cause temporary or medically reversible adverse health consequences. Affected healthcare providers should immediately stop using the product, quarantine remaining inventory, and follow the manufacturer’s instructions for return or disposal.
Tags: pmda, recall, class_ii, orthopedic, surgical_drill, stryker
HSA Updates GN-21 R7 Change Notification Guidance for Registered Medical Devices (Effective Jul 2026)
2026-08-01 | Singapore HSA | Regulation Update | !! MEDIUM
Singapore’s Health Sciences Authority (HSA) has issued revision 7 of Guidance Document GN-21 on change notification for registered medical devices. The updated guidance, effective 31 July 2026, clarifies when and how registrants must notify HSA of changes to their devices. Manufacturers and local representatives should review the revised criteria, update internal change management procedures, and ensure all post-market modifications are correctly reported to avoid non-compliance.
Tags: change_notification, guidance_document, medical_devices, HSA, Singapore
HSA Updates GL-10-R1 Best Practices Guide on Medical Device Cybersecurity
2026-08-01 | Singapore HSA | Regulation Update | !! MEDIUM
The Health Sciences Authority (HSA) has updated guidance document GL-10-R1, 'Best Practices Guide on Medical Device Cybersecurity.' The guide outlines cybersecurity regulatory expectations and best practices for medical device manufacturers, importers, and suppliers in Singapore. Affected stakeholders should review the updated guidance and align pre-market submissions, post-market risk management, and cybersecurity documentation with the latest recommendations.
Tags: medical_device_cybersecurity, hsa_guidance, regulatory_update
MHRA Updates List of Medical Devices Given Exceptional Use Authorisations
2026-07-31 | UK MHRA | Regulation Update | !! MEDIUM
The UK’s MHRA has published its latest decision listing medical devices that have been granted exceptional use authorisations. This exemption permits non-compliant devices to be used in specific clinical situations. The document includes manufacturer names, device details, and current statuses (active, expired, or cancelled). Stakeholders should review the list to verify the status of any devices they supply or use, ensuring continued compliance and patient safety.
Tags: exceptional_use_authorisation, mhra, medical_device_exemption, uk_regulations, list_update
Swissmedic FSCA: MED-STOP Devices in Soft Liner Suction Canister Kits – GMDN Code Correction (Medline Industries LP)
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic field safety corrective action addresses MED-STOP devices included in Medline Industries LP's Soft Liner Suction Canister Kits (models OR53916, OR53926, OR53929, OR54916, OR54926). The correction is due to the Global Medical Device Nomenclature (GMDN) code originally being assigned to the kit rather than the MED-STOP component, which may cause misidentification. Medline is updating the GMDN designation accordingly; users should verify their records reflect the correct nomenclature for the MED-STOP device.
Tags: swissmedic, fsca, gmdn, suction_canister, medline, labeling_correction
Swissmedic Issues Field Safety Corrective Action for Mindray BeneHeart D1 Automated External Defibrillator
2026-07-31 | Swissmedic | Safety Communication | !!! HIGH
The Swiss Agency for Therapeutic Products (Swissmedic) has published a Field Safety Corrective Action (FSCA) for the BeneHeart D1 Automated External Defibrillator manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The specific reason for the correction is not detailed in the brief notice, but the device is classified as a physiologic-monitoring defibrillation system. Affected model is the BeneHeart D1. Healthcare facilities and users should immediately refer to the manufacturer's instructions for the corrective measures and monitor the official Swissmedic notice for further details.
Tags: swissmedic, fsca, defibrillator, mindray, recall
Swissmedic FSCA: Mindray iPM Patient Monitors (Models 5, 6, 7, 8, 10, 12, 9800)
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action for the Mindray iPM Series Patient Monitor. Affected models include 5, 6, 7, 8, 10, 12, and 9800. The reason involves a safety-related issue; users must follow the manufacturer’s corrective instructions to mitigate risks.
Tags: swissmedic, fsca, patient_monitor, mindray, product_correction
Swissmedic FSCA: Mindray TMS40/TMS-6016/TM80 Telemetry Monitors Subject to Field Safety Corrective Action
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Mindray general-purpose multi-parameter bedside telemetry monitors, models TMS40, TMS-6016, and TM80. The specific reason for the corrective action was not detailed in the alert, but users should be aware of potential safety-related concerns. Affected facilities should immediately check their inventory for these models and follow the manufacturer's instructions as communicated by Mindray. Swissmedic advises verifying device compliance and implementing any required corrective measures to maintain patient safety.
Tags: telemetry_monitor, mindray, fsca, swissmedic, field_safety_corrective_action, medical_device
Swissmedic Issues FSCA for Mindray uMEC Series Patient Monitors
2026-07-31 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the uMEC Series bedside multi-parameter patient monitors manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The corrective action addresses a potential safety issue that could affect device performance (specific reason not detailed in the public summary). Affected models include uMEC 6, 7, 10, 12, 15, 15S, 30, 60, 70, 80, 100, 120, and 150. Healthcare facilities should immediately follow the manufacturer's instructions provided in the FSCA notification and contact Mindray for necessary corrective steps.
Tags: swissmedic, fsca, patient_monitor, mindray, safety_alert
Swissmedic FSCA: iMEC Series Patient Monitor by Shenzhen Mindray – Reason Not Disclosed
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the iMEC Series Patient Monitor, a general-purpose multi-parameter bedside monitor manufactured by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. The specific reason for the corrective action and the affected models/lots were not provided in the notice. Healthcare facilities using this device should monitor official channels for further details and follow any instructions from the manufacturer.
Tags: fsca, swissmedic, patient_monitor, mindray, safety_corrective_action
Swissmedic FSCA for Mindray BeneHeart Defibrillator/Monitor Systems (Models D20, D30, D50, D60, D2, D3, D5, D6 and variants)
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a Field Safety Corrective Action for Shenzhen Mindray Bio-Medical Electronics' BeneHeart physiologic-monitoring defibrillation systems. Affected models include D20, D20A, D20C, D30, D50, D50A, D50C, D60, DX, DM, D2, D3, D5, and D6. The manufacturer is implementing a correction; users should consult the FSCA notice for required actions. No specific recall reason was detailed in the notification.
Tags: switzerland, fsca, defibrillator, mindray, field_safety_corrective_action
Swissmedic FSCA for Mindray BeneView T Series Patient Monitors (Models T1/T5/T5S/T5 OR/T6/T8/T9/T9 OR)
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
The Swiss Agency for Therapeutic Products (Swissmedic) issued a Field Safety Corrective Action (FSCA) for Shenzhen Mindray Bio-Medical Electronics Co., Ltd.'s BeneView T Series multi-parameter bedside monitors. Affected models include T1, T5, T5S, T5 OR, T6, T8, T9, and T9 OR. While the specific safety reason was not disclosed in the public notice, healthcare facilities using these devices should immediately consult Mindray or their local representative for the recommended corrective actions, which may involve inspection, software updates, or part replacement.
Tags: swissmedic, fsca, patient_monitor, mindray, safety_corrective_action
Swissmedic Issues FSCA for Mindray Benevision V Series Patient Monitor
2026-07-31 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action (FSCA) for the Benevision V Series patient monitor from Shenzhen Mindray Bio-Medical Electronics. The notice (reference Vk_20260727_033) relates to the general-purpose multi-parameter bedside monitor; however, the specific safety reason and affected model/lot details were not included in the initial alert. Users should consult the full FSCA on the Swissmedic website to identify impacted devices and take recommended corrective actions.
Tags: swissmedic, fsca, patient_monitor, mindray, safety_corrective_action
Swissmedic FSCA: Mindray Benevision N1 Patient Monitor Field Safety Corrective Action
2026-07-31 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Mindray Benevision N1 general-purpose multi-parameter bedside monitor. The notice did not specify the reason or affected model numbers, but typical actions involve a safety-related correction. Healthcare facilities using this device should consult the full FSCA on Swissmedic's platform and follow the manufacturer's instructions.
Tags: fsca, swissmedic, patient_monitor, mindray, safety_corrective_action
SFDA Intercepts Over 301 Tons of Non-Compliant Food Products in Q2 2026
2026-07-31 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) intercepted over 301 tons of non-compliant food products in Q2 2026, highlighting its robust enforcement and digital monitoring capabilities. While the action directly impacts food importers and distributors, medical device manufacturers and regulatory professionals should note SFDA's growing use of digital tools for market surveillance, signaling a broader compliance expectation across all regulated sectors.
Tags: sfda_enforcement, food_safety_interception, digital_transformation, saudi_market_surveillance
SFDA CEO Conducts Field Inspections of Hajj Preparations in Makkah and Eastern Region
2026-07-31 | Saudi SFDA | Regulation Update | ! LOW
The CEO of the Saudi Food and Drug Authority (SFDA) conducted on-site inspections at several facilities in Makkah Al-Mukarramah and the Eastern Region to verify the Authority's readiness for the upcoming Hajj season. The visits focused on ensuring that regulatory and technical services for food, drugs, and medical devices are fully prepared to safeguard pilgrims. While no immediate industry action is required, suppliers of products used during Hajj should expect intensified oversight and compliance checks.
Tags: hajj, sfda_inspection, regulatory_readiness
SFDA Reports 18% Increase in Licensed Drug and Cosmetic Factories and Warehouses in 2025
2026-07-31 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) announced an 18% growth in the number of licensed pharmaceutical and cosmetic factories and warehouses during 2025, crediting its digital transformation and the 'Saudi Green Card' licensing platform. This increase reflects broader regulatory modernization efforts, and manufacturers and warehouse operators in these sectors should continue ensuring their facilities are properly licensed through the online system to maintain compliance.
Tags: sfda, digital_transformation, licensing
SFDA Grants Marketing Authorization for Advanced Biotech Medical Device for Early Alzheimer's Detection
2026-07-31 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) has granted marketing authorization for a medical device that uses advanced biotechnology to enable early detection of Alzheimer's disease. This approval permits the device to be marketed and used in Saudi Arabia, affecting diagnostic device manufacturers and healthcare providers in the region. Regulatory professionals should note this as a significant development in the approval pathway for innovative diagnostic technologies.
Tags: medical_device_approval, alzheimers_disease, biotechnology
SFDA Advances Health Innovation via Clinical Trials, Gene Therapies, and Digital Transformation of Drug Safety
2026-07-31 | Saudi SFDA | Regulation Update | !!! HIGH
The Saudi Food and Drug Authority (SFDA) announced new initiatives to support clinical trials and gene therapies, while also leading a digital transformation in drug and cosmetic safety regulation. The move aims to accelerate innovative treatment development and enhance regulatory oversight. Regulatory professionals should anticipate updated guidelines and new digital platform requirements.
Tags: clinical_trials, gene_therapy, digital_transformation
SFDA Rejects Marketing Authorization for Software Predicting Diabetes 4 Years Before Onset Despite European Marketing
2026-07-31 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) has denied marketing authorization for a software medical device designed to predict diabetes four years before it occurs, citing failure to meet required regulatory standards. The device is already marketed in some European countries, highlighting differing evidence and compliance expectations. This decision affects manufacturers targeting the Saudi market with AI-based diagnostic tools, emphasizing the need for robust clinical validation and full adherence to SFDA’s technical requirements for software as a medical device.
Tags: software_as_medical_device, ai_diagnostics, marketing_rejection, diabetes_prediction, sfda
SFDA Approves Marketing of Novel Brain Stimulation Device for Parkinson's Disease Treatment
2026-07-31 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) has granted marketing authorization for a medical device that uses modern brain stimulation technology to treat Parkinson's disease. This approval allows the device to be placed on the Saudi market, offering patients a new non-pharmacological option. Manufacturers and distributors should note the regulatory pathway for innovative neurostimulation devices in Saudi Arabia and ensure ongoing compliance with SFDA post-market requirements. The device likely falls under a high-risk classification, requiring vigilance and reporting.
Tags: sfda, medical_device_approval, brain_stimulation, parkinsons_disease
MHRA July 2026 Safety Roundup: Latest Medicines and Medical Device Safety Advice
2026-07-30 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA published its monthly Safety Roundup for July 2026, highlighting two new safety advisory entries for medicines and medical device users. Healthcare professionals, patients, and device operators should review the roundup to stay updated on emerging risks and recommended actions. The document consolidates recent Drug Safety Update and Medical Device Alerts, serving as a routine information bulletin for the regulated community.
Tags: mhra, safety_roundup, drug_safety, medical_device_alert, compliance_update
Swissmedic FSCA: Renishaw Mayfield’s neuromate Stereotactic System, Model 001.0050 – Reason Not Detailed
2026-07-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for the neuromate neurological stereotactic surgery system manufactured by Renishaw Mayfield SARL. The affected model is 001.0050. The official notice did not include the specific reason for the corrective action; users should monitor manufacturer communications for instructions.
Tags: swissmedic, fsca, stereotactic_system, neurosurgery, renishaw_mayfield
Class I Recall: Medline TOTAL KNEE-LF Procedure Kit Contains Recalled Bupivacaine Injection
2026-07-29 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is recalling 318 TOTAL KNEE-LF medical procedure convenience kits (Recall #Z-2765-2026) because they contain ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection, USP, which was previously recalled due to quality issues that could lead to serious health hazards. The affected kits were distributed nationwide and pose a Class I recall risk. Healthcare providers should immediately quarantine and return any remaining inventory.
Tags: class_i_recall, convenience_kit, bupivacaine_injection, drug_recall, medical_device_kit
Class I Recall: Medline Industries, LP - MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
2026-07-29 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2747-2026 by Medline Industries, LP. Reason: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was n. Quantity: 60 kits.
Medline Industries Recalls C-Section Convenience Kit (SKU DYNJ910835) Containing Bupivacaine Injection
2026-07-29 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is conducting a Class I recall of its C-SECTION convenience kit (SKU DYNJ910835) because it contains a B. Braun component that includes Bupivacaine Hydrochloride in Dextrose Injection with a potential health hazard. The recall affects 56 kits distributed in the US. Users should immediately quarantine the affected kits and return them to Medline.
Tags: class_i_recall, convenience_kit, bupivacaine_injection, medline_industries, surgical_kit
Class I Recall: Medline Industries, LP - MEDLINE HIP CDS-LF Procedure Kit Contains Recalled Bupivacaine Injection
2026-07-29 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is recalling 52 units of its MEDLINE ‘HIP CDS-LF’ procedure convenience kit after discovering they contain ICU Medical pain management kits with Bupivacaine Hydrochloride in Dextrose Injection, USP that were recalled due to quality issues posing a health hazard. The recall is Class I, the most serious type, because use of the affected product could lead to serious adverse health consequences. Healthcare facilities should immediately quarantine and discontinue use of the affected kits and contact Medline for return or disposal instructions.
Tags: class_i_recall, medline, procedure_kit, bupivacaine, drug_device_combination, pain_management, safety_alert
Class I Recall: Medline Industries, LP - MEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYK
2026-07-29 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2749-2026 by Medline Industries, LP. Reason: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was n. Quantity: 2301 kits.
MHRA Summer Advisory: Keep Medical Devices Safe in Hot Weather, Simple Precautions Urged
2026-07-29 | UK MHRA | Regulation Update | !! MEDIUM
The UK's MHRA has issued a seasonal reminder for patients and caregivers to take extra care with medical devices during hot weather. High temperatures can affect device performance, battery life, and the integrity of temperature-sensitive items like insulin pumps and glucose monitors. The agency advises keeping devices out of direct sunlight, storing them in cool places, and checking manufacturer instructions for safe operating temperature ranges.
Tags: summer_heat_safety, medical_device_care, mhra_advisory
MHRA Published 4 Field Safety Notices for 29 June to 3 July 2026
2026-07-29 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has released a list of 4 Field Safety Notices (FSNs) for the week of 29 June to 3 July 2026. These notices, issued by medical device manufacturers, highlight safety issues that may require corrective actions by healthcare providers or users. Affected organizations should promptly review each notice and implement any recommended measures to ensure patient safety and device compliance.
Tags: field_safety_notice, mhra, medical_device, recall, post_market_surveillance
Philips Azurion Systems Medical Device Recall in Canada Due to Performance Issue
2026-07-29 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall for certain Philips Azurion Systems due to a performance problem that may affect device functionality and patient safety. Healthcare facilities using the affected systems should immediately identify the impacted units, follow the manufacturer's corrective action instructions, and report any related adverse events. This alert highlights the importance of ongoing post-market performance monitoring for interventional imaging systems.
Tags: medical_device_recall, interventional_imaging, performance_issue
PMDA Publishes Report on ASEAN-Japan Medical Devices Regulatory Symposium 2026
2026-07-29 | Japan PMDA | Regulation Update | ! LOW
The PMDA has released the report of the ASEAN-Japan Medical Devices Regulatory Symposium 2026, covering discussions on regulatory harmonization, quality management systems, and post-market surveillance between Japan and ASEAN states. The report offers insights for manufacturers and regulatory professionals active in both regions, though it does not introduce new requirements. It may guide future regulatory alignment and cooperation.
Tags: asean, japan, regulatory_symposium, report, medical_devices
ASEAN-Japan Medical Devices Regulatory Seminar 2026 Announced
2026-07-29 | Japan PMDA | Regulation Update | ! LOW
PMDA has announced the ASEAN-Japan Medical Devices Regulatory Seminar scheduled for 2026. This event will cover regulatory harmonization and updates between Japan and ASEAN countries. Medical device manufacturers seeking market access in these regions should note this upcoming opportunity for regulatory insights. No specific date or registration details are provided yet.
Tags: asean, japan, regulatory_seminar, medical_devices, pmda
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis - W L Gore & Associates Inc
2026-07-29 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Ptfe vascular endoprostheses, straight - other. Reason: . Model: all; all.
FSCA: ORBIS Medication 3.x software by DH Healthcare GmbH may cause medication errors
2026-07-29 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic issued a Field Safety Corrective Action for ORBIS Medication 3.x, a medical device software for medication management by DH Healthcare GmbH. The corrective action addresses a potential defect that could lead to incorrect medication dosage display or administration, posing risks to patient safety. Affected users should immediately verify medication orders and apply the manufacturer's update to mitigate the risk.
Tags: software_recall, medication_error, swissmedic_fsca, field_safety_corrective_action, medical_device_software
MHRA Releases Field Safety Notices for 20–24 July 2026
2026-07-28 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA published its weekly compilation of Field Safety Notices (FSNs) for 20–24 July 2026, covering new alerts for medical devices. These notices inform healthcare providers, users, and manufacturers about identified safety issues and required corrective actions. Affected parties should immediately review the listed notices and implement any mandated field safety corrective actions to ensure continued compliance and patient safety.
Tags: field_safety_notice, mhra, safety_alert
MHRA Field Safety Notices: 20–24 July 2026 Weekly Summary
2026-07-28 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA published a list of field safety notices issued between 20 and 24 July 2026. These notices alert healthcare providers and manufacturers to medical device safety issues requiring corrective action. Affected parties should promptly review the notices and implement recommended measures to maintain patient safety.
Tags: field_safety_notices, mhra, medical_device_safety, weekly_update
Health Canada Recalls Signa MR Systems Over Performance Issues
2026-07-28 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for GE Healthcare's Signa MR systems due to performance issues that may affect image quality and diagnostic accuracy. All healthcare facilities using these MRI systems are affected and should immediately review the safety alert. The manufacturer recommends corrective measures to address the performance defect and ongoing monitoring of affected equipment.
Tags: recall, magnetic_resonance_imaging, performance_issue, health_canada, medical_device
Health Canada Recall Alert: IQecg® Digital ECG Device Due to Performance Issues
2026-07-28 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall alert for the IQecg® Digital ECG device due to performance concerns that may affect the accuracy of electrocardiogram readings. Healthcare facilities and professionals using this device should immediately check the recall notice for specific affected models and follow the manufacturer's instructions for corrective action. The issue could potentially lead to misdiagnosis, so prompt attention is critical. Affected users should contact the manufacturer, Medicalgorithmics S.A., for remediation.
Tags: canada_recall, ecg_device, performance_issue, safety_alert
Health Canada Recalls Blanketrol® II and III 115V Warming Units Over Performance Concern
2026-07-28 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Blanketrol® II 115V and Blanketrol® III 115V hyper-hypothermia units due to a performance issue. The affected devices are used for patient warming and cooling in clinical settings. Healthcare facilities should immediately quarantine the units, cease use, and follow the manufacturer's recall instructions to return or have the devices serviced to prevent potential patient harm.
Tags: medical_device_recall, performance_issue, patient_warming, health_canada
PMDA Class II Recall: Denver Splint (External Nasal Splint) by Meiyu Co., Ltd.
2026-07-28 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall (No. 2-12911) for the Denver Splint, an external nasal splint manufactured by Meiyu Co., Ltd. The recall addresses a potential quality or safety defect that may affect device performance. Healthcare providers and distributors should immediately quarantine impacted units and follow the manufacturer's return or disposal procedures.
Tags: class_ii_recall, nasal_splint, denver_splint, pmda, meiyu
[Class II Recall] Level 1 Hotline Warming Tube (Blood/Fluid Warming Coil) - ICU Medical Japan K.K.
2026-07-28 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA announced a Class II recall (Recall #2-12910) for the Level 1 Hotline Warming Tube, a blood and fluid warming coil manufactured by ICU Medical Japan K.K. The recall is due to a potential quality defect that may affect device safety. Affected healthcare facilities should immediately identify, quarantine, and return the affected units in accordance with the manufacturer's recall instructions.
Tags: class_ii_recall, blood_fluid_warmer, icu_medical_japan, pmda, safety_recall
PMDA Class II Recall: PTA Balloon Catheter II by Firmec Co., Ltd. (Recall No. 2-12909)
2026-07-28 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall for the PTA Balloon Catheter II, a balloon dilatation catheter for percutaneous transluminal angioplasty, manufactured by Firmec Co., Ltd. The recall (No. 2-12909) is due to a potential issue that may affect device performance, such as balloon deflation or rupture. Healthcare facilities are advised to identify and quarantine affected lots, and follow the manufacturer's recall instructions.
Tags: pmda, class_ii_recall, pta_balloon_catheter, firmec, medical_device, japan
ConvaTec Esteem Body Ostomy Pouches: Swissmedic FSCA for Labeling Content Correction
2026-07-28 | Swissmedic | Safety Communication | !! MEDIUM
ConvaTec issued a Field Safety Corrective Action for the Esteem Body 1 Piece Soft Convex Ostomy Pouches (one-piece urostomy bag, open-ended) in Switzerland. The correction updates the English and German versions of the document to fix the distribution date in English, and in German, to include information from the customer care team on product alternatives and to correct a table header. Affected models are listed in the Field Safety Notice; users should ensure they have the updated documentation. This is a medium-priority labeling correction.
Tags: swissmedic, fsca, labeling_correction
Philips Allura and Azurion Patient Tables: Performance Recall Issued by Health Canada
2026-07-27 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall alert for patient tables used in Philips Allura and Azurion interventional X-ray systems due to a performance malfunction that may lead to unintended table movement. This could cause patient falls or injuries during procedures. Healthcare facilities using these systems should immediately review the safety notice, implement recommended mitigations, and contact Philips for corrective actions.
Tags: medical_device_recall, patient_safety, philips
Harmonic Arts Holy Basil Tincture Recalled in Canada Due to Out-of-Specification Total Aerobic Microbial Count
2026-07-27 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for Harmonic Arts Holy Basil Tincture (all lots) due to out-of-specification total aerobic microbial count, which may pose infection risks. Consumers and retailers should immediately stop use or sale and return the product to the place of purchase. No adverse reactions have been reported. Regulatory professionals should note this product quality alert and reinforce microbial monitoring for natural health products.
Tags: recall, microbial_contamination, health_canada
Health Canada Recalls Sphere-9™ Catheter Due to Performance Issues
2026-07-27 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall alert for the Sphere-9™ Catheter due to performance issues that may affect device functionality and patient safety. Healthcare facilities using this catheter should immediately stop using affected lots and follow the manufacturer's recall instructions for product return or replacement. The alert emphasizes that continued use could lead to unreliable diagnosis or therapy delivery.
Tags: recall, catheter, performance_issue
Recall: Spacelabs Healthcare Xhibit® Central Station Performance Issue Safety Alert
2026-07-27 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert concerning a performance issue with the Spacelabs Healthcare Xhibit Central Station, which may compromise the display of patient vital signs. This recall affects healthcare facilities using the device for clinical monitoring. Affected users should immediately verify their device status and apply manufacturer-recommended corrective actions to prevent potential misdiagnosis or delayed treatment.
Tags: medical_device_recall, patient_monitoring, performance_issue, health_canada
Class II Recall: Philips Japan Fetal Monitor FM (分娩監視装置 FM) – Potential Malfunction in Fetal Heart Rate Tracing
2026-07-27 | Japan PMDA | Safety Communication | !! MEDIUM
Philips Japan is conducting a Class II recall of its Fetal Monitor FM (分娩監視装置 FM) due to a potential malfunction that may affect the accuracy of fetal heart rate tracing. This issue could lead to misinterpretation of fetal well-being and delayed clinical intervention. Affected healthcare facilities should immediately follow the manufacturer’s recall instructions, which include device inspection and correction by Philips service personnel.
Tags: class_ii_recall, fetal_monitor, philips_japan, pmda, medical_device_safety
Swissmedic FSCA: Ethicon Gynecare TVT (Model TVTRL) for Incontinence – Field Safety Corrective Action
2026-07-27 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action (FSCA) for the Gynecare TVT device, manufactured by Ethicon SARL. The affected model is TVTRL, described as an incontinence clamp. The specific reason for the correction was not publicly detailed, but users are advised to follow the manufacturer's instructions provided in the FSCA notification to ensure patient safety.
Tags: fsca, swissmedic, incontinence_device, ethicon, gynecare_tvt, field_safety_corrective_action
SFDA NCMDR Weekly Update WU2631 (26 July 2026): Medical Device Safety Alerts
2026-07-26 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi FDA National Center for Medical Devices Reporting (NCMDR) issued Weekly Update WU2631 on 26 July 2026, compiling recent medical device safety alerts, field safety notices, and recall actions. The report identifies affected devices and manufacturers, and outlines required corrective measures for healthcare providers and suppliers in Saudi Arabia. Stakeholders should review the full report promptly and implement the specified actions to mitigate risks to patient safety.
Tags: safety_alert, weekly_update, saudi_sfda, ncmdr, field_safety_notice
MHRA Updates List of Medical Devices with Exceptional Use Authorisations
2026-07-24 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has published an updated list of medical devices and manufacturers granted exceptional use authorisations, allowing market access under specific exemptions. The list covers active authorisations as well as those expired or cancelled. Affected manufacturers, importers, and healthcare providers should review the list to verify the status of devices they supply or use, and take corrective actions if authorisations have lapsed. Regular monitoring of this list is essential for ongoing compliance and patient safety.
Tags: exceptional_use, mhra, medical_device_list, exemption, compliance
Swissmedic FSCA for Philips Azurion Stationary Angiographic X-Ray Systems
2026-07-24 | Swissmedic | Safety Communication | !! MEDIUM
Philips Medical Systems Nederland B.V. has issued a Field Safety Corrective Action (FSCA) for specific models of its Azurion stationary angiographic x-ray systems. The affected models include 722063, 722064, 722067, 722068, 722078, 722079, and a series from 722221 to 722236, 722280 to 722282. The corrective action addresses a potential safety issue, though details are not publicly specified in the notice. Users of these systems should promptly contact Philips or refer to the manufacturer’s instructions for the required corrective measures.
Tags: swissmedic, fsca, angiographic_xray
MHRA Guidance: Compiling a Submission for Clinical Investigations of Medical Devices
2026-07-23 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has issued guidance for sponsors and manufacturers on how to compile a submission to notify them of a clinical investigation of a medical device. It details the required documents, format, and submission process to help ensure regulatory compliance. This guidance is essential for anyone planning a medical device clinical trial in the UK.
Tags: clinical_investigations, mhra_guidance, submission_process
MHRA Guidance: Determining if Your Medical Device Needs a Clinical Investigation in the UK
2026-07-23 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance outlines the criteria for determining whether a medical device must undergo a clinical investigation under UK regulations, or if it qualifies for an exemption. It is aimed at manufacturers and sponsors placing devices on the Great Britain market, providing a step-by-step approach to assess clinical evidence requirements. The document clarifies regulatory expectations to support compliance and streamline the conformity assessment process.
Tags: clinical_investigation, mhra_guidance, medical_devices, uk_regulations, exemption_criteria
UK MHRA Guidance: How to Notify Clinical Investigations for Medical Devices
2026-07-23 | UK MHRA | Regulation Update | !! MEDIUM
This updated MHRA guidance explains the process for sponsors to notify the UK regulator of their intent to conduct a clinical investigation of a medical device. It outlines required documentation, submission steps, and the regulatory pathway under UK legislation. Manufacturers and investigators must follow this guidance to ensure compliance before starting any clinical study involving devices.
Tags: clinical_investigation, mhra_notification, medical_devices, premarket_requirements, uk_regulations
MHRA Guidance on Conducting Clinical Investigations for Medical Devices in Great Britain
2026-07-23 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance details how medical device manufacturers must plan, conduct, and report clinical investigations in Great Britain to comply with the Medical Devices Regulations 2002. It covers regulatory requirements, including the need for MHRA approval, ethical review, and notification of adverse events. Manufacturers and sponsors should use this document to ensure full compliance before initiating any clinical investigation in the GB market.
Tags: clinical_investigations, mhra_guidance, medical_devices, uk_regulations, compliance
MHRA Guidance on Approving Clinical Investigations for Medical Devices
2026-07-23 | UK MHRA | Regulation Update | !! MEDIUM
This guidance outlines how the MHRA decides whether to approve a clinical investigation for medical devices. It is relevant to sponsors and manufacturers planning clinical trials in the UK, detailing the required information and assessment criteria. Key actions include understanding submission requirements, ensuring study designs meet safety and performance standards, and providing robust evidence for approval. The document updates existing guidance to align with current regulatory expectations.
Tags: clinical_investigations, mhra_guidance, medical_devices, approval_process, uk_regulations
Health Canada Recalls HeartSine Samaritan PAD 350P/360P/500P AEDs Due to Membrane Tail Performance Issue
2026-07-23 | Health Canada | Safety Communication | !!! HIGH
Health Canada has recalled the HeartSine Samaritan PAD SAM 350P, SAM 360P, and SAM 500P automated external defibrillators due to a membrane tail defect that may prevent shock delivery during a cardiac emergency. Affected users should immediately inspect their devices and follow the manufacturer’s correction actions. Healthcare facilities must ensure backup AEDs are available until the recalled units are repaired or replaced.
Tags: defibrillator, recall, performance_issue, aed, canada
Health Canada Issues Recall for OverStitch™ Suture Cinch and Suture Cinch–Long Due to Performance Issues
2026-07-23 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the OverStitch™ Suture Cinch and Suture Cinch–Long devices, manufactured by Apollo Endosurgery, due to performance concerns that could compromise device reliability during endoscopic suturing. Healthcare facilities using these devices should immediately identify and quarantine affected inventory, and follow the manufacturer's instructions for return or disposal. Regulatory affairs professionals are advised to verify stock, ensure any adverse events are reported to Health Canada, and communicate the recall to relevant clinical teams.
Tags: medical_device_recall, performance_issue, suture_device, health_canada, endoscopic_surgery
Class II Recall: Meira Compression Hip Screw (Internal Fixation Plate) by Meira Corporation
2026-07-23 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12907) for the Meira Compression Hip Screw, an internal fixation device manufactured by Meira Corporation. The specific safety issue prompting this recall has not been publicly detailed, but the classification indicates a moderate risk where the product may cause temporary or medically reversible health consequences. Healthcare facilities should immediately identify affected inventory, quarantine the devices, and follow the manufacturer’s recall instructions for return or disposal.
Tags: pmda, recall, class_ii, orthopedic_device, hip_screw, meira
Class II Recall: Gunze Medical Cranio Fixation System SHINOBI (Internal Fixation Plate)
2026-07-23 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12906) for the Cranio Fixation System SHINOBI, an internal fixation plate manufactured by Gunze Medical Co., Ltd. This moderate-risk recall addresses a safety issue that could affect device performance. Healthcare facilities should quarantine affected products, stop using them immediately, and follow the manufacturer’s return or disposal instructions.
Tags: japan_pmda, class_ii_recall, cranio_fixation_plate, gunze_medical, shinobi
Swissmedic FSCA for Introducer Kit for Impella by Abiomed/Oscor
2026-07-23 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic issued a Field Safety Corrective Action (FSCA) for the vascular catheter introduction set (Introducer Kit for Impella) manufactured by Abiomed Inc. with Oscor. Affected models include 0052-3046, 0052-3052, 0052-3053, 0052-3006, 0052-3021 and catalogue numbers 0048-0014, 0052-0038, 0052-0039, 1000482, 0052-0011-EU, 0550-0002, 0046-0011, 0052-0002-EU. Users should immediately check inventory, quarantine the affected devices, and follow the manufacturer's instructions for correction.
Tags: swissmedic, fsca, impella, introducer_kit, vascular_catheter, abiomed
HSA Alert: 3 Consumers Including a Child Suffer Serious Adverse Events from Products with Banned/Potent Ingredients
2026-07-23 | Singapore HSA | Regulation Update | !!! HIGH
The Singapore Health Sciences Authority (HSA) issued a press release reporting three consumers, including a 12-year-old, who experienced serious adverse effects after taking products containing banned or potent undeclared medicinal ingredients. The alert warns the public against purchasing and consuming unapproved health products from unknown sources. HSA advises anyone who has taken such products to stop immediately and consult a doctor, and urges the reporting of any adverse events. Regulatory affairs professionals should note heightened enforcement against adulterated health products and review compliance of their own product vigilance systems.
Tags: hsa_alert, serious_adverse_events, banned_medicinal_ingredients, consumer_safety
New MDCG Position Paper Clarifies UDI Assignment Responsibilities Between Manufacturers and Distributors
2026-07-22 | EU MDR/IVDR | Regulation Update | !! MEDIUM
The European Commission has released a new MDCG position paper on assigning Unique Device Identification (UDI) between manufacturers and distributors under the EU Medical Device Regulations. It clarifies which party is responsible for UDI placement when devices are relabeled, repackaged, or sold under a distributor’s own name, covering manufacturers, importers, and distributors. Affected stakeholders should review the guidance to align their UDI assignment processes with the clarified obligations, especially for private labelling and parallel trade scenarios. Timely adoption is essential to maintain compliance with MDR/IVDR traceability requirements.
Tags: udi, mdcg, guidance, manufacturers, distributors, traceability
View Source (European Commission)
Class I Recall: Abiomed Impella CP Set Due to Visually Undetectable Introducer Sheath Leakage
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. has initiated a Class I recall for 87,277 units of its Impella CP Set (Pump Set Code 0048-0003) after identifying a manufacturing defect in 14Fr and 23Fr introducers that can cause leakage from under the sheath cap and along hub score lines. The defect is not visually detectable and poses serious health risks, including bleeding or air embolism. Healthcare providers should immediately stop using affected devices, quarantine them, and follow Abiomed's return instructions.
Tags: class_i_recall, abiomed, impella_cp_set, introducer_leakage, patient_safety
Class I Recall: Abiomed Impella CP Introducer Kit 14Fr (Code 0052-0038) Due to Sheath Leak Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 1,540 units of the Impella CP Introducer Kit 14 Fr, 13 cm (Pump Set Code 0052-0038) because the introducer sheath can leak from under the sheath cap and along hub score lines. The manufacturing defect is not visually detectable and poses serious health risks, including bleeding or air embolism. The firm issued an Urgent Medical Device Recall letter instructing customers to immediately quarantine and return all affected kits.
Tags: class_i_recall, impella_cp_introducer, sheath_leakage, abiomed, medical_device_safety
Class I Recall: Abiomed Impella CP Introducer Kit 14Fr Due to Undetectable Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 846 units of its Impella CP Introducer Kit (14 Fr, 13 and 25 cm, Pump Set Code 1000550) because of a manufacturing issue that can cause introducer sheath leakage under the cap or along hub score lines, which is not visible to the user. If leaks occur, patients may experience bleeding, air embolism, or loss of hemodynamic support, creating a serious health hazard. Healthcare facilities should immediately quarantine and return all affected devices to Abiomed.
Tags: class_i_recall, impella_introducer, sheath_leakage, abio_med, cardiac_device
Oscor Inc. Recalls Abiomed Introducer Kit for Impella Due to Leak Risk (Class I)
2026-07-22 | FDA | recall_class1 | !!! HIGH
Oscor Inc. has initiated a Class I recall of the Abiomed Introducer Kit (REF 0052-3025), a hemostatic peel-away introducer used with Impella catheters, due to manufacturing defects that can cause leakage from the sidearm, under the sheath cap, and along hub score lines. This defect may lead to blood loss, air embolism, or loss of hemostasis, posing serious health risks. The recall covers 355 units distributed in the U.S.; healthcare facilities should immediately stop using affected kits, quarantine all stock, and return them to Oscor Inc.
Tags: class_i_recall, introducer_kit, leak_risk, air_embolism, oscor_inc, impella
Class I Recall: Argon Medical Devices, Inc - General Biospy Tray, REF: GUTS1000
2026-07-22 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2706-2026 by Argon Medical Devices, Inc. Reason: Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility.. Quantity: 1800.
Class I Recall: Argon Medical Devices Arterial Line Kit Due to Non-Sterile Lidocaine Ampules
2026-07-22 | FDA | recall_class1 | !!! HIGH
Argon Medical Devices, Inc. is recalling 440 units of its Arterial Line Kit (REF 400115A) because the kit contains Lidocaine HCL Injection USP 1% ampules that are subject to another recall for failing sterility release criteria. This Class I recall, the most serious type, presents a risk of serious infection or death if the non-sterile solution is used. Customers should immediately quarantine and discontinue use of all affected kits and return them to the firm.
Tags: class_i_recall, sterility_issue, arterial_line_kit
Class I Recall: Abiomed Insertion Kit (JP Set 0052-0011-JP) due to Introducer Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling its ABIOMED Insertion Kit, packaged for Japan (Pump Set Code 0052-0011-JP), containing 14Fr and 23Fr Introducers. The recall is due to a potential for introducer sheath leakage from under the cap and along hub score lines, a manufacturing defect that is not visually detectable and could lead to air embolism or bleeding. A total of 117 units are affected, and customers must immediately quarantine, discontinue use, and return the product.
Tags: class_i_recall, abiomed, introducer_sheath, leakage_risk, patient_safety
Class I Recall: Argon Medical Transvenous Pacing Electrode Tray (REF:0) for Sterility Failure of Lidocaine Ampules
2026-07-22 | FDA | recall_class1 | !!! HIGH
Argon Medical Devices, Inc. is recalling 950 units of its Transvenous Pacing Electrode Tray with Bipolar Balloon Pacing Electrode 5F (REF:0) because the kits contain Lidocaine HCl Injection USP 1% ampules that failed sterility release criteria. This Class I recall indicates a reasonable probability of serious infection risk or other adverse health consequences. Healthcare facilities should immediately quarantine affected products and follow the firm's recall instructions.
Tags: class_i_recall, sterility_failure, pacing_electrode, argon_medical
Class I Recall: Oscor Inc. – Abiomed Introducer Kit for Impella Hemostatic Peel Away Intro – Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Oscor Inc. has initiated a Class I recall for 1332 units of the Abiomed REF 0052-3021 Introducer Kit for Impella Hemostatic Peel Away Intro. Manufacturing issues may cause the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, or along hub score lines, posing risks of blood loss, air embolism, or infection. Healthcare facilities should immediately stop use, quarantine affected products, and return them to Oscor per recall instructions.
Tags: class_i_recall, introducer_sheath_leakage, manufacturing_defect, oscor, abiomed, cardiovascular_device
Class I Recall: Argon Medical Devices One-Piece Introducer Tray Due to Non-Sterile Lidocaine
2026-07-22 | FDA | recall_class1 | !!! HIGH
Argon Medical Devices, Inc. is recalling its One-Piece Introducer Tray (REF 497455, 497434) because the kit contains Lidocaine HCL Injection USP 1% ampules that failed sterility release criteria, prompting a separate recall. This Class I recall affects 200 units distributed in the U.S. and poses a risk of serious infection or sepsis if non-sterile lidocaine is used. Users should immediately quarantine and discontinue use of affected lots, and return products to Argon Medical as directed.
Tags: class_i_recall, sterility_issue, lidocaine, one_piece_introducer_tray, argon_medical, cardiovascular
Class I Recall: Abiomed, Inc. - ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product C
2026-07-22 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2689-2026 by Abiomed, Inc.. Reason: A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by th. Quantity: 35,430 units.
Class I Recall: Abiomed Impella CP 14 Fr Introducer Kit Recalled Due to Undetectable Sheath Leakage
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 1,223 units of the Impella CP Introducer Kit 14 Fr (pump set code 0052-0039) because of potential introducer sheath leakage from under the cap and along hub score lines, a manufacturing defect not visually detectable. This Class I recall poses serious health risks including air embolism, bleeding, or infection. Healthcare providers must immediately quarantine the affected devices and follow Abiomed's return instructions.
Tags: class_i_recall, impella_cp, introducer_sheath, manufacturing_defect
Class I Recall: Argon T-Lok Bone Marrow Trays Due to Non-Sterile Lidocaine Ampules
2026-07-22 | FDA | recall_class1 | !!! HIGH
Argon Medical Devices, Inc. is recalling 850 T-Lok Bone Marrow Trays (REF BMT1104STL, BMET1104TL, BMT1104CATL) because the kits contain Lidocaine HCL Injection USP 1% 5mL ampules subject to another recall for failing sterility release criteria. Use of a non-sterile ampule poses a risk of serious infection, prompting this Class I recall, the most serious type. Affected facilities should immediately quarantine all impacted lots and follow Argon’s instructions for return or disposal.
Tags: class_i_recall, sterility_failure, bone_marrow_tray, argon_medical, lidocaine, medical_device_recall
Class I Recall: Abiomed Impella 5.5 SmartAssist S2 Set Recalled for Introducer Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 1,574 units of the Impella 5.5 SmartAssist S2 Set (pump set codes 1000459, 1000460, JP configuration) due to a manufacturing defect in 14Fr and 23Fr introducers that may cause leakage under the sheath cap or along hub score lines. This Class I recall, the most serious type, warns that the undetectable leak could lead to hemorrhage, air embolism, or inadequate hemodynamic support. The affected devices were distributed in Japan; users must immediately discontinue use, quarantine the product, and contact Abiomed for return and replacement.
Tags: class_i_recall, introducer_sheath_leakage, abiomed_impella, high_risk, medical_device
Class I Recall: Abiomed Impella RP Flex Sets Due to Introducer Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling its Impella RP Flex with SmartAssist Set (pump set code 1000323) because 14Fr and 23Fr introducer sheaths may leak from under the sheath cap and along hub score lines, a manufacturing defect not visually detectable. This could cause bleeding, air embolism, or other serious patient injury. The Class I recall covers 5,017 units distributed in the U.S. Healthcare providers must immediately stop using and quarantine affected products and return them to Abiomed.
Tags: class_i_recall, abiomed, introducer_sheath_leakage
Class I Recall: Abiomed Impella CP Set with Introducer Product C (Code 0048-0044) Due to Introducer Sheath Leakage
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is conducting a Class I recall of 557 units of the Impella CP Set (Pump Set Code 0048-0044) containing Introducer Product C. The recall is due to a manufacturing defect in 14Fr and 23Fr introducers that can cause sheath leakage from under the cap or along hub score lines, not visually detectable. This poses a risk of air embolism, bleeding, or inadequate circulatory support. Users must immediately quarantine affected products and return them to Abiomed.
Tags: class_i_recall, cardiac_assist_device, introducer_leakage, manufacturing_defect, patient_safety
Abiomed Recalls Impella 5.5 Smart Assist Set Due to Introducer Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling its Impella 5.5 Smart Assist Set (pump set codes 1000211 and 1000212) due to potential introducer sheath leakage from under the cap and along hub score lines, a manufacturing defect not visually detectable. This Class I recall, the most serious type, covers 383 units and poses a risk of serious adverse health consequences or death. Customers should immediately quarantine affected products and follow Abiomed's recall instructions.
Tags: class_i_recall, abiomed, impella_5_5, introducer_sheath_leakage, cardiovascular_device, recall_z_2687_2026
Class I Recall: Abiomed Intro Kit (14Fr, JP) Due to Risk of Introducer Sheath Leakage
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 96 units of its ABIOMED Intro Kit, 14Fr x 13 and 25 cm, packaged for Japan (Pump Set Code 0052-0023-JP). The recall was initiated due to a manufacturing defect that may cause introducer sheath leakage from under the sheath cap and along hub score lines; this defect is not visually detectable and could lead to air embolism or bleeding. Users must immediately stop using the affected products, quarantine them, and return them to the firm. This is a Class I recall, the most serious type, indicating a reasonable probability of serious health consequences or death.
Tags: class_i_recall, introducer_sheath_leakage, abiomed, manufacturing_defect, air_embolism, cardiovascular_device
Class I Recall: Abiomed Impella CP Smart Assist Set (JP, Code 0048-0024-JP) for Introducer Sheath Leakage Risk
2026-07-22 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 8,382 units of its Impella CP Smart Assist Set, JP (Pump Set Code 0048-0024-JP) due to potential introducer sheath leakage from under the sheath cap and along hub score lines in 14Fr and 23Fr Introducers. The defect is not visually detectable and could lead to patient complications such as bleeding or vascular injury. Healthcare facilities should immediately quarantine affected products and follow Abiomed’s recall instructions.
Tags: class_i_recall, impella, introducer_sheath, patient_safety
DCA Vantage® HbA1c (DX Claim) Recalled in Canada Over Performance Issues
2026-07-22 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the DCA Vantage® HbA1c (DX Claim) due to performance problems that may lead to inaccurate hemoglobin A1c results. This action affects laboratories and point-of-care settings that rely on the device for diabetes diagnosis and management. Users must immediately discontinue use of impacted lots and follow the manufacturer’s corrective actions. The recall highlights the critical need for robust performance verification of diagnostic claims.
Tags: medical_device_recall, hba1c, performance_issue, diabetes_diagnostics
HeartSine® Samaritan® PAD SAM 350P/360P/500P Recall Due to Labelling and Packaging Issue
2026-07-22 | Health Canada | Safety Communication | !!! HIGH
Health Canada has announced a recall for HeartSine Samaritan PAD automated external defibrillator models SAM 350P, SAM 360P, and SAM 500P due to a labelling and packaging defect. This issue may cause confusion or delays during emergency use by providing incorrect or missing information. Affected users, distributors, and healthcare facilities should immediately verify their devices, follow the manufacturer's corrective actions, and ensure proper labelling is in place.
Tags: medical_device_recall, defibrillator, labelling_issue
Swissmedic FSCA: BD neXus Disposable Infusion Set by MEDCAPTAIN – Safety Correction
2026-07-22 | Swissmedic | Safety Communication | !! MEDIUM
A field safety corrective action has been issued for the BD neXus Disposable Infusion Set, an electric infusion pump administration set for single use, manufactured by MEDCAPTAIN LIFE SCIENCE CO., LTD. Affected models include A211M, A211M1F, A211M5F1, A311M, A311M021F, and A212M1F. The specific reason was not detailed in the initial notice, but users are advised to follow manufacturer instructions, typically involving quarantine and return of affected devices. Further details are available on the Swissmedic FSCA portal.
Tags: fsca, infusion_set, swissmedic, medical_device_safety, medcaptain
Swissmedic Issues Field Safety Corrective Action for Pride Mobility Q6 Edge Electric Wheelchairs
2026-07-22 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Pride Mobility's Q6 Edge 4, Q6 Edge 3 Stretto, and Q6 Edge 3 electric-motor-driven wheelchairs. The action addresses a potential safety concern that could affect occupant-controlled operation. Affected users and healthcare professionals should follow the manufacturer's Field Safety Notice for inspection or correction, and contact Pride Mobility or their supplier for specific instructions.
Tags: swissmedic, fsca, electric_wheelchair, pride_mobility, safety_corrective_action, mobility_aid
Swissmedic FSCA for Straumann BLT Ø4.1mm RC SLActive® 12mm TiZr Dental Implant (Model 021.5312)
2026-07-22 | Swissmedic | Safety Communication | !! MEDIUM
Institut Straumann AG has issued a Field Safety Corrective Action (FSCA) for its BLT Ø4.1mm RC, SLActive® 12mm, TiZr, NTP dental implant (model 021.5312). The Swissmedic notice does not specify the reason for the correction, but distributors and healthcare professionals must follow recommended actions. Affected parties should consult the official FSCA for instructions, which may involve quarantine, return, or enhanced monitoring.
Tags: fsca, swissmedic, dental_implant, straumann
Swissmedic Issues FSCA for Permobil M5 Corpus Electric Wheelchair (Model M5)
2026-07-22 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for the Permobil M5 Corpus electric-motor-driven wheelchair, manufactured by Permobil AB. The specific reason for the corrective action was not detailed in the notice, but the notice targets the M5 model. Affected users and healthcare providers should follow the manufacturer's recommendations and contact Permobil AB for further instructions.
Tags: swissmedic, fsca, permobil, electric_wheelchair, m5_corpus, safety_corrective_action
Swissmedic FSCA: UroDapter Sterile Single-Use Urological Adapter by Pharmico Medical Kft.
2026-07-22 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for UroDapter, a sterile single-use urological adapter from Pharmico Medical Kft. Affected models include date-coded lots 20230228, 20230929, 20240430, 20241031, 20251231, 20260130, and 20260430. While the specific reason is not publicly detailed, healthcare facilities should quarantine affected units and follow the manufacturer's corrective instructions. The notice appears on the Swissmedic FSCA portal.
Tags: swissmedic, fsca, medical_device, urology, sterile_adapter, field_safety_corrective_action, pharmico_medical
Swissmedic FSCA: IALUADAPTER Sterile Urological Adapter by Pharmico Medical Kft.
2026-07-22 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic issued a Field Safety Corrective Action for the IALUADAPTER, a sterile single-use urological adapter from Pharmico Medical Kft. The reason for the corrective action was not specified in the notice, but affected models include 2300023, 2300070, 2400068, 2400133, 2500119, 2500134, and 2600044. Users should immediately quarantine the listed devices and follow the manufacturer's instructions for return or disposal.
Tags: field_safety_corrective_action, urological_device, swissmedic, recall, pharmico_medical
Abiomed Recalls 14Fr Low Profile Catheter Introducer Kits
2026-07-21 | FDA | cdrh_news | !!! HIGH
Abiomed is recalling its 14Fr Low Profile Introducer Kits (used with Impella heart pumps) due to a potential tip separation issue that could lead to vascular injury or procedure delay. The FDA has classified this as a Class I recall, the most serious type, requiring immediate discontinuation of use. Healthcare facilities should quarantine all affected units and follow Abiomed's instructions for return or replacement.
Tags: catheter_introducer_kit, recall, abiomed, impella, class_i, medical_device
B. Braun Medical Removes Spinal Anesthesia Kits Containing Huons Bupivacaine HCl in Dextrose Due to Quality Issue
2026-07-21 | FDA | cdrh_news | !!! HIGH
B. Braun Medical, Inc. is voluntarily removing certain convenience kits that include Huons Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to a potential quality defect that may compromise product integrity, leading to risk for patients. Healthcare facilities should immediately stop using and quarantine affected kits, and contact B. Braun to arrange return. This is a safety-related removal coordinated with FDA CDRH.
Tags: recall, spinal_anesthesia, b_braun, convenience_kit, quality_defect, cdrh
Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine, Bupivacaine, and Saline
2026-07-21 | FDA | cdrh_news | !! MEDIUM
Arrow International is issuing a field correction for certain convenience kits that include Huons-manufactured lidocaine, bupivacaine, and saline separately recalled by Huons due to lack of sterility assurance. The correction involves notifying users to quarantine and remove the affected drug components from the kits and arrange for their return. Healthcare facilities that received the impacted kits should immediately check inventory, stop using the specified drug vials, and follow Arrow International's removal instructions.
Tags: convenience_kit, drug_recall, field_correction, arrow_international, huons, lidocaine, bupivacaine, sterility_assurance
FDA CDRH Town Hall on Biocompatibility and Toxicological Risk Assessment – October 7, 2026
2026-07-21 | FDA | cdrh_news | !! MEDIUM
The FDA's Center for Devices and Radiological Health (CDRH) is hosting a virtual Town Hall on biocompatibility and toxicological risk assessment on October 7, 2026. The event provides medical device manufacturers and stakeholders an opportunity to engage with FDA experts on current expectations, challenges, and evolving best practices for demonstrating biocompatibility under ISO 10993. Attendees can submit questions in advance and participate in live discussions to clarify regulatory pathways for chemical characterization and toxicological risk assessment.
Tags: biocompatibility, toxicological_risk_assessment, town_hall, cdrh, iso_10993, medical_devices
FDA CDRH Town Hall on Biocompatibility and Chemical Characterization: Focus on Extractions (Sep 23, 2026)
2026-07-21 | FDA | cdrh_news | !! MEDIUM
The FDA's Center for Devices and Radiological Health (CDRH) will host a virtual town hall on September 23, 2026, dedicated to biocompatibility and chemical characterization testing with a specific focus on extraction protocols. Medical device manufacturers preparing premarket submissions should attend to understand current expectations for extraction study design, solvent selection, and data interpretation. This event provides a direct opportunity to ask questions and clarify regulatory requirements under ISO 10993-18 and related guidance.
Tags: biocompatibility, chemical_characterization, extractions, town_hall, iso_10993, fda_cdrh
FDA CDRH Announces Town Hall on Biocompatibility Risk Assessment on September 9, 2026
2026-07-21 | FDA | cdrh_news | !! MEDIUM
The FDA’s Center for Devices and Radiological Health (CDRH) will hold a town hall on September 9, 2026, focused on biocompatibility risk assessment for medical devices. This event is intended for medical device manufacturers and regulatory affairs professionals seeking clarity on current expectations for biocompatibility evaluation. Participants will have the opportunity to engage directly with FDA experts, ask questions, and discuss best practices. Manufacturers are encouraged to register in advance and prepare specific questions related to their biocompatibility assessment strategies.
Tags: biocompatibility, risk_assessment, town_hall, cdrh, medical_device, regulatory_affairs
MHRA Field Safety Notices Published 13–17 July 2026
2026-07-21 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA has published a list of Field Safety Notices (FSNs) issued between 13 and 17 July 2026. These notices alert healthcare professionals, patients, and device manufacturers to specific safety issues with medical devices. Recipients should review the list to identify any affected devices in their care or on the market and take the corrective actions detailed in each notice.
Tags: field_safety_notice, mhra, medical_devices, safety_alert, uk
MHRA Updates Public List of Suspended and Revoked Licences for Medicine Manufacturers and Wholesalers, Adding 8 New Entries
2026-07-21 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has published an updated decision list of companies whose licences or registrations to manufacture or wholesale medicines and active pharmaceutical ingredients have been suspended or revoked. The update adds 8 new entries to the existing public register. Affected entities include manufacturers and wholesalers who have failed to meet regulatory standards. Industry stakeholders should review the list to assess any potential impact on their supply chains or business partners.
Tags: uk_mhra, licence_suspension, medicines_manufacturing, regulatory_enforcement, supply_chain_compliance
MHRA Weekly Field Safety Notices Roundup: 13-17 July 2026
2026-07-21 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA publication lists 8 Field Safety Notices (FSNs) issued for medical devices during the week of 13 to 17 July 2026. Healthcare professionals and organizations should review the notices to identify affected devices in their inventory and follow the manufacturer-recommended actions. The notices cover various device categories and safety issues.
Tags: field_safety_notice, mhra, weekly_listing, medical_devices, post_market_surveillance
Shimadzu X-ray High Voltage Generators Recalled in Canada Over Performance Issue
2026-07-21 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert for Shimadzu X-ray High Voltage Generators due to a performance issue. Healthcare facilities using these generators should immediately check if their units are affected by the recall. The recall may require corrective actions such as repair or replacement to ensure safe and accurate operation. Users are advised to contact Shimadzu for specific instructions and to report any adverse events.
Tags: canada_recall, x-ray_generator, shimadzu, performance_issue, safety_alert
Cardinal Health Recalls Presource® Kits with Ritmed® Neurological Sponges Due to Sterility Issue
2026-07-21 | Health Canada | Safety Communication | !!! HIGH
Cardinal Health has initiated a voluntary recall of select Presource® kits that contain Ritmed® Neurological Sponges because the sponges may have compromised sterility. The affected kits were distributed across Canada and are used in neurological procedures. Healthcare facilities should immediately locate and quarantine all units from the impacted lots, and arrange for their return to Cardinal Health. Use of non-sterile devices could lead to serious patient infections.
Tags: medical_device_recall, sterility, neurosurgical_sponge, safety_alert, cardinal_health
Class II Recall: Shimadzu LIGHTVISION and LIGHTVISION2 Near-Infrared Camera Systems (Portable Surgical Microscope & ICG Fluorescence Device)
2026-07-21 | Japan PMDA | Safety Communication | !! MEDIUM
Shimadzu Corporation has initiated a Class II recall (No. 2-12903) in Japan for its LIGHTVISION and LIGHTVISION2 near-infrared camera systems, which include portable surgical microscopes and ICG fluorescence observation devices. The recall is due to a potential quality or safety issue that may lead to temporary or reversible health consequences. Affected users should immediately identify and quarantine the devices, and follow the manufacturer's instructions for correction or return.
Tags: japan_pmda, class_ii_recall, near_infrared_camera, shimadzu, lightvision, surgical_microscope, icg_fluorescence
PMDA Class II Recall of Nisshin 救急バンPS Adhesive Bandage (Recall #2-12902)
2026-07-21 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA issued a Class II (moderate risk) recall for 救急バンPS adhesive bandage by Nisshin Medical Instrument Co., Ltd. (recall #2-12902). The recall addresses a quality issue that may compromise product safety. Users should stop using affected lots immediately and return or dispose per manufacturer instructions.
Tags: pmda, class_ii_recall, adhesive_bandage, japan, medical_device, nisshin_medical
Class II Recall: GE Healthcare Japan Carestation 600/750 Series Anesthesia Systems
2026-07-21 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall (No. 2-12901) for GE Healthcare Japan's Carestation 600 and 750 series anesthesia systems. This moderate-level recall is due to a safety-related issue with the device. Affected users should immediately follow the manufacturer's recall notification and implement any recommended corrective actions.
Tags: recall, class_ii, anesthesia_system, ge_healthcare, pmda
PMDA Class II Recall of Intuitive Surgical’s NIR Camera System (Endoscopic Video Camera)
2026-07-21 | Japan PMDA | Safety Communication | !! MEDIUM
Intuitive Surgical’s NIR Camera System (endoscopic video camera) is the subject of a Class II recall in Japan (Recall No. 2-12900), indicating a moderate risk. The specific safety issue or reason for the recall was not detailed in the initial notice. Healthcare facilities using this device should consult the PMDA recall database and follow any manufacturer instructions to address the recall.
Tags: pmda_recall, class_ii, intuitive_surgical, endoscopic_camera, nir_camera, medical_device, japan
FSCA Update: Stryker Hoffmann II Micro Connecting Rods - Response Deadline Change
2026-07-21 | Swissmedic | Safety Communication | !! MEDIUM
Stryker GmbH has issued a Field Safety Corrective Action (FSCA) for its Hoffmann II Micro connecting rods, part of external bone fixation systems. The sole purpose of this action is to update the response deadline for previously communicated corrective measures. Affected model numbers are 50796030, 50796040, 50796050, 50796060, 50796090, 50796120, and 50796150. Users should note the revised deadline and ensure their responses are submitted accordingly.
Tags: swissmedic, fsca, stryker, external_fixation, hoffmann_ii_micro, deadline_update
Swissmedic FSCA: Medtronic Sphere-360 Catheter (AFR-00012) – Language Addition Correction
2026-07-21 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for the Medtronic Sphere-360 cardiac ablation catheter (model AFR-00012) due to an added language in its labeling. This is a product correction, not a recall, requiring no product return. Healthcare facilities and distributors should ensure the updated labeling is in place and continue using the device safely.
Tags: fsca, medtronic, labeling_update
Swissmedic Issues FSCA for MEDICO TECHNOLOGIES Sterile Single Use Tear Duct Cannula (S-140097, S-140096)
2026-07-21 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Sterile Single Use Tear Duct Cannula manufactured by MEDICO TECHNOLOGIES, affecting models S-140097 and S-140096. The specific reason for the corrective action was not detailed in the public notice, though it pertains to lacrimal duct devices. Healthcare facilities are advised to immediately identify and quarantine affected units and follow the manufacturer's instructions for return or correction.
Tags: swissmedic, fsca, medical_device_recall, lacrimal_cannula, medico_technologies
Swissmedic FSCA for Aesculap AG Silver Graft (Helix) Vascular Prosthesis – Model Info in FSN
2026-07-21 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Silver Graft (Helix) Vascular Prosthesis, a synthetic non-medicated graft from Aesculap AG. The specific reason for the action is not detailed in the public notice; affected model and lot numbers are provided in the manufacturer's Field Safety Notice (FSN). Healthcare providers should immediately identify impacted devices, consult the FSN, and follow recommended actions, which typically include quarantine and return.
Tags: swissmedic, fsca, vascular_prosthesis, aesculap_ag, implant, field_safety_corrective_action
MHRA Guidance: Register Medical Devices to Place on the Market in Great Britain and Northern Ireland
2026-07-20 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has issued updated guidance on the mandatory registration of medical devices before they can be placed on the Great Britain and Northern Ireland markets. It applies to manufacturers, authorised representatives, and importers, detailing the registration process, use of the Public Access Registration Database (PARD), and alignment with the UK Medical Devices Regulations 2002. The guidance covers initial registration, updates, and compliance timelines, emphasising that no device can be marketed without valid MHRA registration.
Tags: medical_device_registration, mhra, uk_market_access, pard, compliance
MHRA Issues Guidance on Legal Requirements for Prosthetic, Orthotic and Ophthalmic Devices
2026-07-20 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has published new guidance detailing the specific regulations that apply to manufacturers of prosthetic, orthotic and ophthalmic medical devices. The document clarifies obligations for conformity assessment, registration and post-market surveillance under the UK Medical Devices Regulations. Manufacturers of these specialized devices should review the guidance to ensure full compliance and avoid regulatory gaps. This update continues MHRA’s effort to offer sector-specific regulatory clarity.
Tags: mhra_guidance, prosthetics_orthotics_ophthalmics, legal_requirements
MHRA Issues Guidance on Compliance for Custom-Made Medical Devices in Great Britain
2026-07-20 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance outlines the regulatory requirements for manufacturing custom-made medical devices in Great Britain under the UK Medical Devices Regulations 2002. It explains who qualifies as a manufacturer of custom-made devices, what documentation and quality system obligations apply, and how to demonstrate conformity. Manufacturers must review these expectations to ensure they meet legal duties and maintain market access.
Tags: custom_made_devices, uk_mhra, regulatory_guidance, medical_device_compliance
Health Canada Notice: Information Expectations for Class III and IV Medical Device Licence Applications
2026-07-20 | Health Canada | Regulation Update | !! MEDIUM
This Health Canada notice outlines the specific information and documentation expectations for Class III and IV medical device licence applications. Manufacturers of these higher-risk devices must ensure submissions include quality system certificates, detailed device descriptions, and clinical evidence as applicable. The guidance aims to streamline reviews and reduce deficiencies. Affected companies should update their regulatory dossiers to align with the stated expectations.
Tags: canada, class_iii_iv_devices, licence_application, health_canada_notice, regulatory_guidance
Philips Achieva and Ingenia MRI Systems – Performance Issue Safety Alert
2026-07-20 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert for certain Philips Achieva and Ingenia MRI systems due to a performance issue that may compromise image quality. The affected systems could produce suboptimal images, potentially leading to delayed or missed diagnoses. Healthcare facilities using these systems should immediately contact Philips for inspection and follow the manufacturer’s recommended corrective actions to ensure safe and effective operation.
Tags: recall, safety_alert, mri_system
SFDA NCMDR Weekly Safety Update WU2630 (19 July 2026) Released
2026-07-19 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) has published Weekly Update report WU2630. This report compiles recent medical device safety alerts, field safety notices, and adverse event reports for healthcare providers and manufacturers. Stakeholders are advised to review the document, identify affected devices listed within, and implement any recommended corrective actions to ensure continued compliance and patient safety.
Tags: sfda, ncmdr, weekly_safety_update, medical_device_reporting, field_safety_notice
Recall: Thermo Fisher Neisseria meningitidis Gp C Antisera (R30166901) Fails IFU Performance, Not Positive within 60 Seconds
2026-07-17 | FDA | Safety Communication | !!! HIGH
The FDA has issued a Class I recall for specific lots of Remel Europe Ltd. / Thermo Fisher Diagnostics Neisseria meningitidis Gp C antisera (R30166901). The affected product does not yield a positive reaction with the ATCC13102 control strain within 60 seconds as required by the instructions for use, potentially leading to false-negative results. Misidentification of Neisseria meningitidis serogroup C may delay appropriate treatment and infection control measures, posing serious health risks. Laboratories should immediately discontinue use of the impacted lots, quarantine remaining inventory, and contact Thermo Fisher for replacement. All results obtained with these lots should be re-evaluated.
Tags: device_recall, fda_safety_alert, invitro_diagnostics, neisseria_meningitidis, false_negative, class_i_recall
MHRA Updates List of Medical Devices with Exceptional Use Authorisations (Including Expired/Cancelled Exemptions)
2026-07-17 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has published an updated list of manufacturers and medical devices granted exceptional use authorisations (exemptions), as well as those whose authorisations have expired or been cancelled. This transparency document allows stakeholders to verify which devices may be lawfully placed on the UK market under special conditions. Affected manufacturers should review the list to confirm their product’s status and ensure compliance with any conditions attached. Regulatory professionals should monitor the list for changes that may impact market access.
Tags: exceptional_use_authorisation, mhra, medical_devices, exemption_list, uk_regulation
UK MHRA Updates Guidance: List of Approved Bodies for Medical Device Conformity Assessments
2026-07-17 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has released updated guidance listing the organisations currently approved to conduct conformity assessments on medical devices. Manufacturers and authorised representatives must consult this list to identify valid Approved Bodies for UKCA or CE marking purposes. The document details each body’s designation scope, enabling stakeholders to verify which bodies can assess specific device categories. Staying informed about the latest approved bodies is critical for maintaining compliance and market access in Great Britain.
Tags: uk_mhra, approved_bodies, conformity_assessment, medical_devices, guidance_update
Health Canada Issues Recall for 4K UHD LCD Monitor Due to Performance Issue
2026-07-17 | Health Canada | Safety Communication | !! MEDIUM
Health Canada has issued a medical device recall for a 4K UHD LCD monitor due to a performance issue that may compromise its clinical function. Affected healthcare facilities and professionals should immediately verify affected serial numbers and follow the manufacturer's corrective action instructions to prevent potential diagnostic or procedural errors.
Tags: medical_device_recall, canada, performance_issue, lcd_monitor, health_canada
Merge PACS
2026-07-17 | Health Canada | Safety Communication | !! MEDIUM
Performance
Recall of ER-Spec Single-Use Vaginal Speculum with LED Light Source Due to Performance Issues
2026-07-17 | Health Canada | Safety Communication | !! MEDIUM
Health Canada has issued a recall of the ER-Spec Single-Use Vaginal Speculum with LED Light Source because of performance concerns that may compromise device functionality during examination. The recall affects healthcare facilities that use these devices. Users should immediately quarantine all affected units, discontinue use, and follow the manufacturer’s return or disposal instructions to ensure patient safety.
Tags: recall, vaginal_speculum, performance_issue, canada_health, single_use_device, led_light_source
Health Canada Recalls Atellica CH Urine Albumin (UAlb) Test Due to Performance Issues
2026-07-17 | Health Canada | Safety Communication | !! MEDIUM
Health Canada has issued a recall for the Atellica® CH Urine Albumin (UAlb) assay, a clinical chemistry test used to measure urine albumin levels, because of a performance problem that may lead to inaccurate results. Laboratories using the affected product are instructed to stop using the impacted lots immediately and to contact Siemens Healthineers for further guidance. The recall aims to prevent misdiagnosis or inappropriate clinical management of patients relying on albumin-to-creatinine ratio assessments.
Tags: recall, ivd, urine_albumin, performance_issue, siemens_healthineers, health_canada
PMDA Class II Recall: Mesh Carrier (Skin Graft Expander) by Keisei Medical Industry
2026-07-17 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall (No. 2-12899) for the Mesh Carrier (autologous skin graft expander) manufactured by Keisei Medical Industry Co., Ltd. This recall addresses a safety issue with the device used in skin grafting procedures. Healthcare facilities should immediately check their inventory, quarantine affected products, and follow the manufacturer's instructions for return or disposal.
Tags: japan_pmda, class_ii_recall, skin_graft_expander, mesh_carrier, medical_device
Biofire Defense Recalls FilmArray NGDS Warrior Panel Due to Outbreak Strain Mismatch
2026-07-16 | FDA | Safety Communication | !!! HIGH
Biofire Defense has recalled the FilmArray NGDS Warrior Panel (REF NGDS-ASY-0007, UDI-DI (01)00851458005136) because the reference strains used in test development do not match circulating outbreak strains, which may cause false negative or inaccurate results. Affected product should be immediately removed from use, quarantined, and returned or disposed of as directed by the firm. The FDA has classified this as a Class II recall (Z-2877-2026).
Tags: device_recall, class_ii_recall, ivd_panel, nucleic_acid_test, biofire_defense, filmArray, safety_alert
Health Canada Issues Recall for Solar™ GI Device Due to Performance Failure
2026-07-16 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall for the Solar™ GI due to performance issues. The device may fail to operate as intended, potentially impacting diagnostic or therapeutic procedures in gastroenterology. Healthcare facilities should immediately quarantine affected lots and follow manufacturer instructions for return or replacement. This alert is part of a recent batch of 14 safety communications.
Tags: health_canada, medical_device_recall, performance_issue, gastroenterology, safety_alert
Health Canada Recalls Cardiac Workstation Over Performance Issue Causing Possible Misdiagnosis
2026-07-16 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Cardiac Workstation due to a performance problem that may produce inaccurate cardiac analysis, posing a risk of misdiagnosis and inappropriate patient management. Healthcare facilities using this device should immediately verify any diagnostic results with alternative methods and contact the manufacturer for corrective actions. The recall affects specific models or lots; users must identify affected units and follow the safety alert instructions without delay.
Tags: medical_device_recall, performance_issue, cardiac_diagnostics
Health Canada Recalls Philips Allura Xper FD Series Due to Performance Issue
2026-07-16 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Philips Allura Xper FD series interventional X-ray systems because of a performance problem that could affect device function. The affected devices may not meet performance specifications, potentially impacting clinical procedures. Healthcare facilities should immediately follow Philips' field safety notice to inspect and, if necessary, correct the systems. Regulatory affairs professionals must ensure awareness of this recall and coordinate response actions with clinical engineering teams.
Tags: recall, health_canada, imaging_system, performance_issue
Health Canada Recalls StrykeFlow PS and AHTO Devices Over Performance Failure
2026-07-16 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall for the StrykeFlow PS and AHTO products due to performance issues that could compromise device effectiveness and patient safety. The recall affects specific lots distributed to healthcare facilities across Canada. Users are instructed to immediately quarantine affected units, identify them by lot number, and arrange return to the manufacturer. This safety alert requires prompt action to prevent potential clinical disruptions.
Tags: medical_device_recall, performance_failure, health_canada, safety_alert
Health Canada Alert: SEMA 3 Device Compatibility Issue May Affect Data Display and Connectivity
2026-07-16 | Health Canada | Safety Communication | !! MEDIUM
Health Canada has issued a medical device alert for SEMA 3, a data management system used to aggregate and display information from multiple medical devices. The alert warns of a device compatibility issue that could lead to incorrect data presentation, delayed or lost data transmission, potentially impacting clinical decisions. Healthcare providers using SEMA 3 should immediately verify system compatibility with connected devices and contact the manufacturer for corrective actions.
Tags: device_compatibility, recall, data_management, software
Health Canada Recalls V-Loc™ 90 and 180 Suture Products Over Sterility Issues
2026-07-16 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for V-Loc™ 90 and 180 suture products due to a sterility breach that may compromise product safety. Healthcare facilities and professionals who use these barbed sutures are affected and must immediately quarantine and discontinue use of the affected lots. The recall requires identification and return of the non-sterile units to prevent potential patient infections. Affected institutions should follow Health Canada's safety alert and report any adverse incidents.
Tags: medical_device_recall, sterility, suture, canada, v_loc
CTP Tubing Sets Recalled Due to Potential Sterility Compromise
2026-07-15 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall of CTP tubing sets because of a sterility failure that could expose patients to infectious risks. The affected devices have been distributed to Canadian healthcare facilities. Immediate action is required: quarantine remaining stock, discontinue use, and follow the manufacturer's return or disposal instructions.
Tags: sterility, recall, tubing_sets, medical_device, health_canada
Presource Kits with Teleflex Pilling Wecksorb Neurosponge Recalled in Canada Over Performance Issue
2026-07-15 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for certain Presource surgical kits that include the Teleflex Pilling Wecksorb Neurosponge, a hemostatic agent used in neurological procedures, due to a performance failure that may compromise its ability to control bleeding. Affected products could pose serious risks to patients if they fail to perform as intended during surgery. Healthcare facilities and distributors are advised to immediately quarantine and stop using the impacted lots, and follow the manufacturer's instructions for product return. This safety alert applies to all parties in the Canadian supply chain.
Tags: canada, recall, neurosurgery, hemostatic_sponge, performance_issue
Health Canada Recall: Leoni Plus Medical Device – Performance Issue
2026-07-15 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Leoni Plus medical device due to a performance defect that may compromise its function or safety. Healthcare providers and facilities using this device should verify affected lots, discontinue use as instructed, and follow the manufacturer’s corrective actions. This alert underscores the importance of monitoring device performance and reporting adverse events.
Tags: medical_device_recall, performance_issue, canada, health_canada, safety_alert
Class II Recall for Nipro NAZ-1 Blood Purification Device in Japan (Recall No. 2-12897)
2026-07-15 | Japan PMDA | Safety Communication | !! MEDIUM
Japan's PMDA has issued a Class II (moderate risk) recall for the NAZ-1 multi-purpose blood processing device by Nipro Corporation. The alert references recall number 2-12897, though the specific safety issue and corrective actions were not detailed in the initial notification. Healthcare facilities and users of this device should review the official PMDA recall notice for full instructions.
Tags: japan, class_ii_recall, blood_purification_device, nipro, pmda
PMDA Class II Recall: Nipro SafeTech Pro Syringe Pump Unit
2026-07-15 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA issued a Class II recall (No. 2-12896) for the SafeTech Pro Syringe Pump Unit, a syringe-type infusion pump manufactured by Nipro Corporation. The recall addresses a potential performance issue that could affect infusion accuracy or device reliability. Affected healthcare facilities should immediately review the recall notice, identify devices with the specified serial numbers, and follow Nipro's instructions for corrective action such as inspection, repair, or replacement.
Tags: pmda_recall, class_ii, syringe_pump, infusion_pump, nipro, medical_device, safety_correction
Swissmedic FSCA: Philips Cardiac Workstation 7000 Electrocardiograph, Model 860441 (Reason Not Specified)
2026-07-15 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Philips Medizin Systeme Böblingen GmbH Cardiac Workstation 7000, a professional multichannel electrocardiograph, model 860441. The specific reason for the corrective action was not detailed in the public notice. Users should contact Philips or their local representative for the necessary corrective measures, which may involve a software update, hardware inspection, or other risk mitigation steps to ensure device safety and performance.
Tags: switzerland, fsca, electrocardiograph, philips, safety_corrective_action, medical_device
Philips Cardiac Workstation 5000 (Model 860439) Swissmedic Field Safety Corrective Action
2026-07-15 | Swissmedic | Safety Communication | !! MEDIUM
Philips Medizin Systeme Böblingen GmbH has issued a Field Safety Corrective Action (FSCA) for the Cardiac Workstation 5000, a professional multichannel electrocardiograph. The affected model is 860439. While the specific reason was not detailed in the Swissmedic notice, users should contact Philips or follow the manufacturer's instructions for required actions. This FSCA is registered under Swissmedic reference Vk_20260702_031.
Tags: fsca, swissmedic, electrocardiograph, philips, medical_device, field_safety_corrective_action
Swissmedic FSCA for Covidien BOX BYPASS KIT (Model BOX09222V1) – December 2025 Action
2026-07-15 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action (FSCA) for the BOX BYPASS KIT, model BOX09222V1, manufactured by Covidien llc. The notice, dated December 2025, alerts users to a safety-related issue requiring corrective measures. Affected healthcare facilities should immediately review the manufacturer's instructions, which may involve product inspection, quarantine, or return. Detailed rationale and required actions are provided in the full FSCA, accessible via Swissmedic's portal.
Tags: swissmedic, fsca, covidien, box_bypass_kit, safety_corrective_action
Swissmedic FSCA: Covidien V-Loc 180 Bioabsorbable Sutures – Models VLOCL0024, VLOCL0306, and Others
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for specified models of the V-Loc 180 polyester, bioabsorbable, monofilament, non-antimicrobial suture manufactured by Covidien llc. The affected model numbers are VLOCL0024, VLOCL0306, VLOCL0316, VLOCL0604, VLOCL0644, VLOCL0804, VLOCL2105, VLOCL2145, and VLOCL2246. While the notice does not detail the specific reason, healthcare facilities should identify and quarantine the affected products and follow the manufacturer's instructions to prevent potential patient risk.
Tags: swissmedic, fsca, covidien, v_loc_180, suture, recall
Swissmedic FSCA: V-Loc 90 Barbed Suture by Covidien llc (Models VLOCM0003, VLOCM0013, VLOCM0604)
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for V-Loc 90, a barbed polyester suture manufactured by Covidien llc. The affected models are VLOCM0003, VLOCM0013, and VLOCM0604. While the specific reason was not detailed in the notice, healthcare facilities should identify and quarantine affected lots, and follow the manufacturer's instructions for return or correction.
Tags: barbed_suture, field_safety_corrective_action, swissmedic, covidien
Swissmedic FSCA on Medtronic MiniMed 640G Insulin Pump Models MMT-1711, MMT-1712
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Medtronic MiniMed 640G ambulatory insulin infusion pumps, covering electronic pump models MMT-1711 and MMT-1712. The reason for the corrective action is not publicly detailed in the notification. Users and healthcare professionals should follow the manufacturer's immediate recommendations and contact Medtronic for further instructions.
Tags: fsca, swissmedic, insulin_pump, medtronic, corrective_action, safety
Swissmedic FSCA: Medtronic MiniMed 670G Insulin Pump – Software-Dosing Scalar Algorithm Correction
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for the Medtronic MiniMed 670G ambulatory insulin infusion pump (models MMT-1781, MMT-1782) due to a potential issue in the software-dosing scalar algorithm. Healthcare professionals and patients using the affected devices should immediately consult the manufacturer’s instructions to mitigate any insulin delivery risk. Medtronic is expected to provide a software correction or other remedial actions.
Tags: swissmedic, fsca, insulin_pump, software_correction, medtronic, recall
Swissmedic FSCA: Medtronic MiniMed 780G Insulin Pump Software-Dosing Algorithm Correction
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic issued a Field Safety Corrective Action for the Medtronic MiniMed 780G ambulatory insulin infusion pump (models MMT-1885CLW and MMT-1886CLW) due to a potential issue with its electronic software-dosing scalar algorithm. The corrective action aims to mitigate risks associated with the affected software. Users and healthcare providers are advised to contact Medtronic for the recommended corrective steps, which may include software updates or device inspection.
Tags: swissmedic, fsca, insulin_pump, medtronic, software_correction, medical_device_safety
Swissmedic FSCA: Hollister Onli & Infyna Hydrophilic Intermittent Catheters – Safety Correction
2026-07-15 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for specific models of Hollister Incorporated's Onli and Infyna hydrophilic urethral intermittent catheters. The action affects multiple catalog numbers including 82081, 82121, 88081, 82084, 85124, and others listed in the notice. Affected devices are single-administration urethral drainage catheters, and users should immediately follow the manufacturer's instructions provided in the field safety notice. No specific reason is publicly detailed, but the corrective action indicates a potential risk requiring risk mitigation measures.
Tags: fsca, swissmedic, catheter_recall, hollister, urology_device
Swissmedic FSCA: Shimadzu Diagnostic X-ray System Generators UD150B-40/UD150V-40/UD150L-40/UD150L-40E/F
2026-07-15 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Shimadzu stationary diagnostic X-ray system generators, models UD150B-40, UD150V-40, UD150L-40, and UD150L-40E/F. The notice does not specify the reason for the corrective action. Affected users should refer to Swissmedic case number Vk_20260713_052 for required actions.
Tags: fsca, swissmedic, x-ray, diagnostic_imaging, shimadzu, medical_device_correction
EC Publishes Dashboard v3.5 for Monitoring Medical Device Availability on the EU Market
2026-07-14 | EU MDR/IVDR | Regulation Update | !! MEDIUM
The European Commission has released version 3.5 of the dashboard supporting its study on the availability of medical devices in the EU market. This update provides enhanced data visualization for stakeholders, including manufacturers, notified bodies, and competent authorities, to monitor device supply trends and potential shortages. The dashboard aids in assessing the impact of the MDR/IVDR transition on market access. Affected parties should consult the new version for current market intelligence and compliance planning.
Tags: medical_device_availability, dashboard_update, market_surveillance, eu_mdr
View Source (European Commission)
Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Catheter Delivery Catheter System (DCS)
2026-07-14 | FDA | cdrh_news | !! MEDIUM
CDRH News
CDRH News: FDA Small Business Determination (SBD) Program Offers Reduced or Waived Medical Device User Fees
2026-07-14 | FDA | cdrh_news | !! MEDIUM
This CDRH news item provides an overview of the FDA’s Small Business Determination (SBD) program, which allows qualifying small businesses to receive reduced or waived user fees for certain medical device premarket submissions. Eligible firms must meet gross receipts thresholds and submit an SBD request using Form 3602 or 3602A. The update clarifies eligibility criteria, application steps, and the need for an active SBD number before submitting a fee‑based application. Manufacturers are advised to apply early to avoid processing delays.
Tags: small_business, user_fee, sbd_program, cdrh_news, medical_device
MHRA Field Safety Notices Summary: 6–10 July 2026
2026-07-14 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA has published its weekly list of Field Safety Notices (FSNs) for the period 6 to 10 July 2026. This compilation contains safety alerts and corrective actions for medical devices and in-vitro diagnostics distributed in the UK. Affected healthcare providers and users should review the specific notices for device models and implement recommended actions without delay. Regulatory affairs professionals are advised to monitor these notices for potential impacts on their product portfolios.
Tags: field_safety_notices, mhra, medical_device_safety
Class II Recall: Boston Scientific Japan OverStitch Single-Use Automatic Suturing Device
2026-07-14 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12894) for the OverStitch single-use automatic suturing device, manufactured by Boston Scientific Japan. The recall addresses a potential safety or performance issue that could compromise device function during use. Affected healthcare facilities should immediately quarantine unused devices, discontinue use, and contact the manufacturer for return or proper disposal. This moderate-risk recall requires prompt action to prevent patient harm.
Tags: class_ii_recall, surgical_suture_device, boston_scientific, pmda, medical_device_safety
Class II Recall: Clean Air ASTRAL Adult Ventilator by ResMed Ltd. (Japan PMDA Recall No. 2-12893)
2026-07-14 | Japan PMDA | Safety Communication | !! MEDIUM
The Japan PMDA has issued a Class II recall (No. 2-12893) for the Clean Air ASTRAL adult ventilator manufactured by ResMed Ltd. This recall is due to a potential safety concern that could affect device performance, posing a moderate risk to patients. Healthcare facilities should immediately identify affected units, discontinue use if necessary, and contact the manufacturer for inspection, repair, or replacement as appropriate.
Tags: japan_pmda, class_ii_recall, ventilator, resmed, safety
Swissmedic FSCA: Kröber O2 Oxygen Concentrator – Correction of Duplicate Model/Catalog Numbers
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action (FSCA) for Kröber O2 oxygen concentrators (models KRO2.00, KR4.00) because duplicate entries in model and catalog numbers have been corrected. This is a documentation correction and does not involve a product recall. Affected users and distributors should refer to the updated manufacturer information to ensure correct identification of the devices.
Tags: swissmedic, fsca, oxygen_concentrator, kroeber, model_correction
Swissmedic FSCA: Schiller AG SEMA Clinical Data Interfacing Software (Models 0A.602010, 0A.602030, 0A.602000, 0A.602020)
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Schiller AG's SEMA medical equipment clinical data interfacing software. The affected models are 0A.602010, 0A.602030, 0A.602000, and 0A.602020. While the specific reason for the corrective action was not detailed in the public notice, users should review the FSCA documentation and follow any manufacturer or Swissmedic recommendations.
Tags: medical_device, fsca, swissmedic, software, clinical_data, schiller, product_correction
Swissmedic FSCA: Boston Scientific OverStitch Suture Cinch Models M00505530 and M00505540
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
The Swiss Agency for Therapeutic Products (Swissmedic) issued a Field Safety Corrective Action for the OverStitch Suture Cinch, a single-use suture/ligature tightener manufactured by Boston Scientific Corporation. The affected models are M00505530 (GTIN: 00191506060046) and M00505540 (GTIN: 00191506049171). The specific reason for the corrective action was not detailed in the notification, but users should follow the manufacturer's instructions. Affected devices should be identified, quarantined, and handled per Boston Scientific's guidance.
Tags: medical_device, fsca, switzerland, suture_tightener, boston_scientific, recall
Swissmedic FSCA for Boston Scientific Suture Cinch–Long (Model M00505550)
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action for the Boston Scientific Suture Cinch–Long, a single-use suture/ligature tightener, model M00505550 (GTIN: 00191506049188). The reason for the corrective action is not specified in this notification. Healthcare facilities using this device should follow the manufacturer’s instructions, which may include quarantine and return of affected units.
Tags: field_safety_corrective_action, swissmedic, surgical_device, boston_scientific
Swissmedic FSCA for Maquet Critical Care Flow-i and Flow-e Anesthesia Workstations
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action for Maquet Critical Care AB's Flow-i C20, C30, C40, Flow-c, and Flow-e general-purpose anesthesia workstations. The notice identifies affected model numbers and article codes, including various Flow-i configurations. Users should consult the manufacturer's correction instructions and implement the recommended actions to maintain device safety and performance.
Tags: swissmedic, fsca, anesthesia_workstation, maquet_critical_care
FSCA: Fritz Stephan GmbH Eve Neo Ventilators, Models 107061420 & 107061401
2026-07-14 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Fritz Stephan GmbH's Eve Neo adult and paediatric/neonatal pulmonary ventilators, affecting models 107061420 and 107061401. The specific reason for the corrective action was not detailed in the public notice, but it involves a safety-related issue. Affected users should immediately consult the manufacturer's instructions provided through the FSCA and implement any required corrective measures to ensure safe device operation.
Tags: swissmedic, fsca, ventilator, field_safety_corrective_action, fritz_stephan, eve_neo
Safety Alert: Oxylog 600 Ventilators from Fritz Stephan GmbH (Models 107161400, 107161401)
2026-07-14 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic issued a Field Safety Corrective Action (FSCA) for Oxylog 600 adult and paediatric/neonatal pulmonary ventilators manufactured by Fritz Stephan GmbH. The action affects models 107161400 and 107161401. The specific reason was not detailed in this alert, but users should follow the manufacturer's safety notice and implement any required corrective measures immediately.
Tags: fsca, ventilator, safety_alert, swissmedic, recall
Eve In - Fritz Stephan GmbH
2026-07-14 | Swissmedic | Safety Communication | !! MEDIUM
FSCA: MD: Adult and paediatric/neonatal pulmonary ventilators. Reason: . Model: 107061410, 107061411; .
Health Canada Recalls Oribe Serene Scalp Densifying Shampoo Due to Bacterial Contamination
2026-07-13 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for Oribe Serene Scalp Densifying Shampoo due to the presence of bacterial contamination. The affected product may pose a risk of infection, especially for individuals with weakened immune systems or broken skin. Consumers are advised to immediately stop using the shampoo and return it to the place of purchase for a refund.
Tags: product_recall, bacterial_contamination, health_canada_alert, cosmetic_safety, consumer_advisory
Japan PMDA Class II Recall: Dilasoft Cervical Dilator by TKB Co., Ltd.
2026-07-13 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall for the Dilasoft cervical dilator (子宮頚管拡張器) manufactured by TKB Co., Ltd. (株式会社ＴＫＢ). This recall addresses a potential quality issue that could affect device safety or performance. Healthcare providers should immediately quarantine and return affected units to the manufacturer.
Tags: japan_pmda, class_ii_recall, cervical_dilator, medical_device
Class II Recall: Atom Medical FSV Central Monitor (Recall #2-12887)
2026-07-13 | Japan PMDA | Safety Communication | !! MEDIUM
Atom Medical Corporation has issued a Class II recall (No. 2-12887) for its FSV Central Monitor due to a potential safety issue that could affect device performance. Affected devices should be immediately taken out of service, and healthcare facilities should follow the manufacturer's instructions for return or corrective action. The recall notice is posted on the PMDA website for further details.
Tags: recall, class_ii, central_monitor, atom_medical, patient_monitoring, japan_pmda, medical_device_safety
SFDA NCMDR Weekly Update WU2629 (12 July 2026) – Medical Device Safety Report
2026-07-12 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) released Weekly Update WU2629 on 12 July 2026, summarizing recent medical device field safety notices, recalls, and safety alerts from the week. Affected devices and manufacturers are detailed in the report, and all stakeholders—including importers, distributors, and healthcare providers—should immediately review the notices and implement necessary corrective actions to maintain compliance and safeguard patients.
Tags: saudi_sfda, ncmdr, weekly_update, medical_device_safety, field_safety_notice
MHRA Updates List of Medical Devices Granted Exceptional Use Authorisations, Including Cancellations
2026-07-10 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has published an updated list of manufacturers and medical devices that have received exceptional use authorisations, along with those whose exemptions have expired or been cancelled. Affected stakeholders include device manufacturers, importers, and healthcare providers who rely on such authorisations for continued market access. Organisations should review the list to confirm the current status of any devices they supply or use, and take immediate action if an authorisation has been revoked to ensure compliance.
Tags: mhra, exceptional_use_authorisation, medical_device_exemption, regulatory_decision, market_access
Class II Recall: Cerabian ZR Dental Porcelain by Kuraray Noritake Dental Inc.
2026-07-10 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12886) for Cerabian ZR, a dental porcelain product manufactured by Kuraray Noritake Dental Inc. The recall addresses a specific quality or safety concern; healthcare professionals should consult the official notice for details. Affected users must immediately stop using the involved lots and contact the manufacturer for appropriate corrective actions.
Tags: dental_porcelain, class_ii_recall, japan_pmda, medical_device, cerabian_zr
BLEPHADEMODEX Sterile Skin-Cleaning Wipe: Swissmedic FSCA by Laboratoires Théa
2026-07-10 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for BLEPHADEMODEX, a sterile skin-cleaning wipe manufactured by Laboratoires Théa. The reason for the corrective action has not been specified in the notice. Affected model and lot numbers are not detailed; however, users should immediately quarantine the product and follow the manufacturer's instructions for return or disposal. This action underscores the importance of sterility assurance in medical devices.
Tags: fsca, swissmedic, sterile_wipe, medical_device, recall, laboratoires_thea, blephademodex
Astral 150 Ventilator Recall in Canada Due to Performance Issue Posing Ventilation Loss Risk
2026-07-09 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for ResMed's Astral 150 ventilator due to a potential internal fan stall that may cause a sudden loss of ventilation therapy. The affected devices are from specific lots distributed in Canada. Users must have an alternate means of ventilation available and contact ResMed to arrange repair or replacement. Healthcare providers should immediately quarantine and identify all impacted units.
Tags: medical_device_recall, ventilator, astral_150
Recall: Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod – Sterility Issue
2026-07-09 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert for the Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod due to a sterility concern. This device, used in foot and ankle surgeries, may not be sterile and poses an infection risk to patients. Healthcare facilities should immediately quarantine affected units, stop using the product, and follow the manufacturer’s recall instructions for return or disposal.
Tags: medical_device_recall, sterility, health_canada, infection_risk, orthopedic_device
Health Canada Recalls ºM Warmer Medical Device Due to Performance Failure
2026-07-09 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the ºM Warmer due to performance issues that may compromise its intended function. The recall affects healthcare facilities and professionals using the device, as the failure could pose risks to patient safety. Users are instructed to immediately stop using the product and follow the manufacturer’s instructions for return or remediation. This safety action is part of a new batch of seven Canadian medical device alerts.
Tags: medical_device_recall, performance_issue, health_canada, patient_safety, warming_device
Class II Recall: Fukuda Denshi Servo Ventilator System (General-Purpose Ventilator)
2026-07-09 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12885) for the Servo Ventilator System, a general-purpose ventilator manufactured by Fukuda Denshi Co., Ltd., due to a potential safety issue. Healthcare facilities using this device should immediately review the recall notice and follow the manufacturer’s instructions for corrective action.
Tags: pmda_recall, class_ii, ventilator, fukuda_denshi, medical_device_safety
Swissmedic FSCA: Getinge Disinfection AB Warming Cabinets Model 363 – General-Purpose Drying Cabinet
2026-07-09 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Getinge Disinfection AB's general-purpose drying cabinet, marketed as warming cabinets, model 363. The specific reason for the corrective action is not detailed in the notice, but the manufacturer is taking necessary measures to address a potential safety or performance issue. Affected users should follow the manufacturer's instructions provided through the FSCA and contact Getinge Disinfection AB for further guidance.
Tags: swissmedic, fsca, warming_cabinet
Class I Recall: Insulet Corporation - Omnipod 5 Pods (POD-OMNI-I1-6720) Due to Cannula Damage and Insulin Leakage
2026-07-08 | FDA | recall_class1 | !!! HIGH
Insulet Corporation is recalling 4,936,056 Omnipod 5 Pods (model POD-OMNI-I1-6720) because a manufacturing defect in the external soft cannula may cause insulin to leak around the Pod, leading to under-delivery. This Class I recall—the most serious type—poses risks of hyperglycemia and diabetic ketoacidosis. Users should immediately check their device and contact Insulet for a replacement or further guidance.
Tags: class_i_recall, insulin_pump, omnipod, cannula_damage, insulin_leakage, patient_safety
Class I Recall: Baxter's Hillrom VOLARA System Patient Circuit Kits Recalled Due to Air and Medication Leakage from Nebulizer Cup
2026-07-08 | FDA | recall_class1 | !!! HIGH
Baxter Healthcare Corporation has initiated a Class I recall for 16,187 units of its Hillrom VOLARA System P.CIRCUIT KIT AC (single patient use circuit) due to reports of air and medication leakage from the nebulizer cup. This leakage can cause a drop in the patient's oxygen level and ineffective therapy, posing a serious health hazard. The FDA classifies this as the most serious type of recall; healthcare providers should immediately stop using affected circuits, quarantine them, and return the products to Baxter.
Tags: class_i_recall, nebulizer_leakage, respiratory_device
Class I Recall: Hamilton Medical AG Coaxial Breathing Circuit Set – Sticking Valve Membranes Risk Obstructed Exhalation
2026-07-08 | FDA | recall_class1 | !!! HIGH
Hamilton Medical AG has initiated a Class I recall for its coaxial breathing circuit sets (REF 260127, 260128, 260167, 260168) used with Hamilton Medical ventilators. The expiratory valve membranes may stick to the valve body, an issue not detectable during pre-operative testing, causing an 'exhalation obstructed' alarm and potentially leading to ventilation failure and serious patient harm. The recall covers 27,270 units distributed in the U.S. Users should immediately quarantine the affected products, identify them by reference number, and contact the manufacturer for replacement or further instructions per the recall notice.
Tags: class_i_recall, ventilator, breathing_circuit, exhalation_valve
Class I Recall: Insulet Corporation - Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5
2026-07-08 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2604-2026 by Insulet Corporation. Reason: External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode . Quantity: 1,790,784 units.
Class I Recall: Windstone Medical Packaging Recalls AMS7200D Surgical Kits Due to Contaminated Alcohol Prep Pads
2026-07-08 | FDA | recall_class1 | !!! HIGH
Windstone Medical Packaging, Inc. is conducting a Class I recall of its AMS, Aligned Medical Solutions, Dr. Lewin Pack (Pack Number AMS7200D) surgical kits because they contain Webcol Large Alcohol Prep Pads recalled by Cardinal Health. The prep pads were found to be contaminated with Paenibacillus phoenicis, posing a risk of serious infection. Only 45 units are affected. Customers should immediately quarantine and return any affected kits to the recalling firm.
Tags: class_i_recall, windstone_medical_packaging, alcohol_prep_pad, microbial_contamination, surgical_kit
Class I Recall: Windstone Medical Packaging’s AMS Thyroid FNA Pack-RX Contains Recalled Contaminated Alcohol Prep Pads
2026-07-08 | FDA | recall_class1 | !!! HIGH
Windstone Medical Packaging, Inc. is recalling 200 units of Aligned Medical Solutions Thyroid FNA Pack-RX (pack number AMS17729) because the kits include Webcol Large Alcohol Prep Pads that were recalled by Cardinal Health after a contaminant, Paenibacillus phoenicis, was found during a routine sterilization dose audit. This Class I recall is the most serious type, as use of the contaminated prep pads could lead to life-threatening infections, particularly in immunocompromised patients. The products were distributed to medical facilities performing thyroid fine-needle aspiration procedures. Customers must immediately stop using the kits, quarantine all affected units, and return them to Windstone Medical Packaging.
Tags: class_i_recall, contaminated_device, alcohol_prep_pad, thyroid_fna_kit, windstone_medical, paenibacillus_phoenicis
Class I Recall: Baxter's Hillrom VOLARA System Circuit Kits – Nebulizer Cup Leakage Can Drop Patient Oxygen Levels
2026-07-08 | FDA | recall_class1 | !!! HIGH
Baxter Healthcare Corporation has issued a Class I recall for 13,881 units of its Hillrom VOLARA System P.CIRCUIT 5KIT AC single-patient use circuits. Air and medication leakage from the nebulizer cup during therapy may cause a drop in the patient's oxygen level and reduce treatment effectiveness. This recall, the most serious type, requires healthcare providers to immediately cease using affected circuits, quarantine them, and follow Baxter's return or disposal instructions. No injuries have been reported yet, but the hazard is significant.
Tags: class_i_recall, fda, baxter, volara, respiratory_device, safety_alert
Medtronic Recalls Harmony Delivery Catheter System Due to Distal Tip Detachment Risk (Class I Recall)
2026-07-08 | FDA | recall_class1 | !!! HIGH
The FDA has classified Medtronic Heart Valves Division's recall of its Harmony Delivery Catheter System as Class I due to a potential for distal tip detachment from specific manufacturing lots. This issue may lead to embolization, vascular injury, or the need for emergency surgical intervention. A total of 1,881 units are affected. Healthcare providers should immediately stop using the affected lots, quarantine the products, and follow Medtronic's instructions for return and patient management.
Tags: class_i_recall, medtronic, harmony_delivery_catheter, tip_detachment, fda_recall
Medline Industries Recalls Reprocessed Electrophysiology and Ultrasound Catheters Due to Particulate Contamination (Z-2615-2026)
2026-07-08 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is conducting a Class I recall of specific lots of reprocessed electrophysiology and ultrasound catheters (Recall #Z-2615-2026). The devices may contain small residual particles on patient-contacting surfaces, posing a risk of embolization or other serious harm if used. This recall expands RES 98277 and affects 3 units. Healthcare facilities should immediately quarantine affected products and follow the firm’s return or disposal instructions.
Tags: class_i_recall, particulate_contamination, reprocessed_catheters, patient_safety_hazard
Class I Recall: Windstone Medical DSAEK Pack-RX Kits with Contaminated Alcohol Prep Pads
2026-07-08 | FDA | recall_class1 | !!! HIGH
Windstone Medical Packaging, Inc. is recalling 1,080 DSAEK Pack-RX surgical kits (Pack Number AMS12394B) because they include Webcol Large Alcohol Prep Pads that were recalled by Cardinal Health after routine sterilization audits detected Paenibacillus phoenicis contamination. Use of the affected kits could lead to serious infections in surgical patients. Healthcare providers should immediately quarantine all kits, stop usage, and return them to the recalling firm.
Tags: class_i_recall, surgical_kit, alcohol_prep_pad
Class I Recall: Windstone Medical Packaging Preop Kit-NS (AMS18227) Due to Contaminated Alcohol Prep Pads
2026-07-08 | FDA | recall_class1 | !!! HIGH
Windstone Medical Packaging, Inc. has issued a Class I recall for ALIGNED MEDICAL SOLUTIONS Preop Kit-NS, pack number AMS18227, following the contamination of included Webcol Large Alcohol Prep Pads with Paenibacillus phoenicis. The pads were previously recalled by Cardinal Health after the contaminant was discovered during a routine sterilization dose audit, posing a risk of serious infection. The recall covers 200 units distributed in the U.S. Users should immediately quarantine and discontinue use of the affected kits, and return them to the recalling firm.
Tags: class_i_recall, contamination, surgical_prep_kit, alcohol_prep_pad, paenibacillus_phoenicis, windstone_medical_packaging, aligned_medical_solutions, recall_z-2621-2026
Class I Recall: Insulet Corporation - Omnipod (Eros) Pod due to Cannula Damage and Insulin Leakage
2026-07-08 | FDA | recall_class1 | !!! HIGH
Insulet Corporation is recalling 289,046 units of its Omnipod (Eros) Pod (model POD-ZXP425) due to external soft cannula damage during manufacturing, which can cause insulin to leak around the Pod instead of being delivered, potentially leading to under-delivery and hyperglycemia. The FDA has classified this as a Class I recall, the most serious type, indicating a reasonable probability of serious adverse health consequences or death. Users should immediately inspect their Pods, discontinue use of affected lots, and contact Insulet for replacements while monitoring blood glucose closely.
Tags: class_i_recall, omnipod, insulin_pump, cannula_damage
Class I Recall: Baxter Healthcare Hillrom VOLARA System P.CIRCUIT KIT – Nebulizer Cup Leakage Causing Oxygen Drop
2026-07-08 | FDA | recall_class1 | !!! HIGH
Baxter Healthcare Corporation has initiated a Class I recall of 10,540 units of the Hillrom VOLARA System P.CIRCUIT KIT due to air and medication leakage from the nebulizer cup during therapy. This fault can cause a drop in the patient's oxygen level and render treatment ineffective, posing serious health risks. All affected circuits should be immediately quarantined and returned to Baxter for replacement.
Tags: class_i_recall, respiratory_device, nebulizer_leakage, patient_safety, fda
Baxter Recalls Hillrom Volara P.Circuit 5KIT Due to Nebulizer Cup Leakage Causing Oxygen Drop
2026-07-08 | FDA | recall_class1 | !!! HIGH
Baxter Healthcare Corporation is conducting a Class I recall of the Hillrom Volara P.Circuit 5KIT (single patient use circuit) because of air and medication leakage from the nebulizer cup during therapy. This defect can lead to a dangerous drop in the patient’s oxygen level and render the treatment ineffective. The recall impacts zero units (likely a field correction notification), and users must immediately discontinue use of affected circuits and follow the manufacturer’s instructions.
Tags: class_i_recall, baxter_healthcare, hillrom_volara, circuit_leakage, oxygen_desaturation, nebulizer_defect
MHRA Updates Guidance on Registering Medical Devices for Great Britain and Northern Ireland Markets
2026-07-08 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has updated its guidance on how to register medical devices for the Great Britain and Northern Ireland markets. Manufacturers and authorised representatives must register their devices with the MHRA before placing them on the market, following class-specific routes and deadlines. The guidance addresses both UKCA and CE marking requirements for Northern Ireland.
Tags: medical_device_registration, mhra_guidance, uk_market_access, regulatory_update
Philips Allura Xper FD10 Interventional X-ray System – Performance Issue Safety Alert
2026-07-08 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert regarding the Allura Xper FD10 interventional X-ray system due to a performance issue that may affect image quality and diagnostic reliability. Affected devices could potentially lead to procedural delays or misdiagnosis. Healthcare facilities should immediately verify their system's status, follow the manufacturer's corrective actions, and report any adverse events. Philips is providing inspection and remediation guidance to impacted users.
Tags: medical_device_recall, imaging_system, performance_issue, philips, health_canada, interventional_radiology
Health Canada Recalls Unauthorised Alice Le System Sleepware Software
2026-07-08 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Alice Le System Sleepware Software, an unauthorised medical device used for sleep diagnostics. The software was found to be sold without the required medical device licence. Healthcare facilities should immediately stop using the product, quarantine it, and follow the manufacturer’s return or disposal instructions. Unauthorised devices may pose unknown risks to patient safety and data integrity.
Tags: unauthorised_device, sleep_diagnostic_software, canada_recall
Two Lots of Omnitrope Human Growth Hormone Injection Recalled in Canada Due to Cracked Cartridges
2026-07-08 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for two specific lots of Omnitrope (somatropin) injectable human growth hormone after receiving reports of cracked cartridges. This defect poses a risk of compromised sterility, potentially leading to infection or reduced efficacy for patients. Healthcare professionals and users are urged to immediately stop using product from the affected lots, quarantine remaining inventory, and contact Sandoz Canada for return and replacement. The recall highlights the importance of robust container integrity for parenteral drug-device combination products.
Tags: recall, cartridge_defect, sterility_risk
Swissmedic FSCA: Comecer IRIS Infusion Pump – Added German Language Version (Model 0246010026)
2026-07-08 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action for Comecer Netherlands B.V.'s IRIS infusion pump, model number 0246010026. The action was taken to provide a German language version of the device documentation, addressing the risk of use errors among German-speaking users. Affected units should be updated with the new German documents following the manufacturer's instructions.
Tags: swissmedic, fsca, infusion_pump, comecer, german_language, product_correction
Swissmedic Issues FSCA for Philips Allura Stationary Angiographic X-Ray Systems
2026-07-08 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for Philips Allura stationary angiographic X-ray systems manufactured by Philips Medical Systems Nederland B.V. The affected models are 722026, 722027, 722028, 722029, 722035, 722038, 722039, and 722058. Although the specific reason for the corrective action was not detailed in the notice, users are required to contact Philips immediately for instructions to ensure safe operation.
Tags: swissmedic, fsca, philips_allura, angiographic_x_ray, medical_device_recall
Olympus OEV321UH 4K UHD Monitor Recall: Faulty HDMI/DisplayPort Connectors May Cause Image Loss
2026-07-07 | FDA | Safety Communication | !!! HIGH
Olympus Corporation of the Americas is recalling its OEV321UH 4K UHD LCD Monitor (Recall Z-2761-2026) because the HDMI and DisplayPort connectors can become faulty, leading to image loss or image abnormalities during use. This defect poses risks of misdiagnosis or surgical complications if the monitor is relied upon for visualization. The FDA has issued this as a serious safety communication. Healthcare providers should immediately identify and cease use of affected units, and contact Olympus for remediation instructions.
Tags: recall, olympus, hdmi_dp_fault
Device Recall: INTEGRATED MEDCRAFT LLC - FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-4
2026-07-07 | FDA | Safety Communication | !! MEDIUM
Recall Z-2836-2026: Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
Recall: Integrated Medcraft Kingfisher First Aid Kit (REF 76656) – Guedel Airway Occlusion Hazard
2026-07-07 | FDA | Safety Communication | !!! HIGH
Integrated Medcraft LLC is recalling its Kingfisher Compact Individual First Aid Kit (REF 76656) because the included one-piece Guedel airway may have a fully or partially occluded tip. This defect could obstruct airflow, delaying emergency ventilation and potentially causing serious injury or death. Distributors and end-users should immediately quarantine affected kits and contact the firm for return or replacement.
Tags: recall, fda_safety_communication, airway_obstruction, first_aid_kit, guedel_airway, integrated_medcraft
MHRA Releases Compilation of Field Safety Notices for 29 June – 3 July 2026
2026-07-07 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA has published its weekly summary of Field Safety Notices (FSNs) issued by medical device manufacturers during 29 June to 3 July 2026. This list covers a range of devices and includes mandatory actions such as recalls, software updates, or device inspections. Healthcare providers, device users, and distributors should review the notices to identify affected products and implement the recommended safety measures immediately.
Tags: field_safety_notice, mhra, medical_device, recall, safety_alert, uk_regulation
Class II Recall of Noritsu Precision Enteral Feeding Pump CP-55E (Enteral Nutrition Infusion Pump) in Japan
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall for the Enteral Feeding Pump CP-55E, an enteral nutrition infusion pump manufactured by Noritsu Precision Co., Ltd. This recall addresses a safety-related issue that may affect device performance or labeling. Healthcare facilities using this pump should immediately identify affected units, cease use if instructed, and follow the manufacturer’s corrective actions as detailed in the recall notice.
Tags: class_ii_recall, enteral_feeding_pump, pmda_japan
Philips Japan Recalls Integris Allura Flat Detector, Allura Centron, and Azurion Cardiac X-Ray Fluoroscopic Systems (Class II)
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
Philips Japan has initiated a Class II recall (No. 2-12881) for three stationary digital cardiac X-ray fluoroscopic diagnostic devices: Integris Allura Flat Detector, Allura Centron, and Azurion. This recall addresses a moderate safety risk that may affect device performance or patient safety. Healthcare facilities using these systems should immediately follow the manufacturer's field safety corrective action, which may involve inspection, software update, or part replacement, and contact Philips Japan for guidance.
Tags: philips, allura, azurion, cardiac_x_ray, class_ii_recall, pmda_japan
Class II Recall: Covidien Japan V-Loc90 & V-Loc180 Barbed Suture Closure Devices
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
Covidien Japan has issued a Class II recall (No. 2-12880) for its V-Loc90 and V-Loc180 barbed closure devices, which use polyglycomer and polyglyconate sutures respectively. The recall addresses a potential manufacturing defect that may compromise suture integrity, posing a risk of wound dehiscence or prolonged healing. Healthcare providers must immediately identify and quarantine affected lots, discontinue use, and arrange product return to the manufacturer.
Tags: recall, class_ii, suture, barbed_suture, covidien, pmda
PMDA Class II Recall: Sensitouch Synthetic Rubber Surgical Gloves (Non-Latex) by Toray Medical (Recall No. 2-12879)
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA issued a Class II recall for Sensitouch synthetic rubber surgical gloves manufactured by Toray Medical Co., Ltd. This moderate-risk recall addresses a potential quality defect that could compromise glove integrity. Healthcare providers must immediately identify and quarantine affected lots, cease use, and follow the manufacturer's return or disposal instructions as detailed in recall notice 2-12879.
Tags: surgical_gloves, class_ii_recall, non_latex, pmda, toray_medical, product_safety
Swissmedic FSCA: BAL Flush Syringe SS, 10 ml by Jiaxing Tianhe Pharmaceutical
2026-07-07 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for the BAL Flush Syringe SS, 10 ml (model BAL 464013) manufactured by Jiaxing Tianhe Pharmaceutical Co., Ltd. The specific reason for the corrective action has not been disclosed, but it concerns the pre-filled syringes. Healthcare facilities should identify affected products, quarantine them, and follow the manufacturer's instructions for return or disposal.
Tags: swissmedic, fsca, medical_device, prefilled_syringe, recall
Swissmedic FSCA: Boston Scientific Rapid Refill Continuous Injection System Cholangiography Tubing Set
2026-07-07 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for the Boston Scientific Rapid Refill Continuous Injection System, specifically the Cholangiography tubing set (GTIN 08714729285151, UPN M00566001). The reason for the corrective action is detailed in the manufacturer's notification. Healthcare facilities should identify affected devices, quarantine them, and follow Boston Scientific’s instructions to mitigate any safety risks.
Tags: swissmedic, fsca, boston_scientific, cholangiography_tubing, medical_device, safety_corrective_action, switzerland
MHRA Updates Guidance on Clinical Investigation Notifications for Medical Devices
2026-07-06 | UK MHRA | Regulation Update | !! MEDIUM
The UK's MHRA has published updated guidance outlining the process for notifying the regulator about planned clinical investigations for medical devices. Sponsors and manufacturers must submit specific notification forms with required documentation before starting a study in the UK. This update ensures clarity on regulatory obligations and patient safety requirements for all parties involved in medical device clinical investigations.
Tags: clinical_investigations, mhra, notification, medical_devices, uk_regulations, guidance_update
Health Canada Recalls Hotline IV Fluid Warmer System & Accessories Due to Performance Concerns
2026-07-06 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert and recall for the Hotline IV Fluid Warmer System and its accessories due to performance issues that may compromise patient safety. Affected devices can fail to deliver fluids at the intended temperature, potentially leading to patient harm. Healthcare facilities should immediately identify and quarantine affected units, discontinue use, and follow the manufacturer's instructions for return or correction.
Tags: medical_device_recall, iv_fluid_warmer, performance_issue, health_canada, safety_alert
Class II Recall of VITROS XT7600, 5600II, 5600, 4600 Clinical Chemistry Analyzers by Ortho Clinical Diagnostics in Japan
2026-07-06 | Japan PMDA | Safety Communication | !! MEDIUM
Japan's PMDA announced a Class II recall (No. 2-12877) for Ortho Clinical Diagnostics' VITROS XT7600, 5600II, 5600, and 4600 discrete clinical chemistry analyzers due to a potential performance issue. Affected devices may produce inaccurate results, necessitating a field correction. Healthcare facilities should immediately follow the manufacturer's notification for inspection, software update, or device replacement to mitigate patient risk.
Tags: pmda, class_ii_recall, vitros, clinical_chemistry_analyzer, ortho_clinical_diagnostics, safety
Class II Recall of Nemuri SCAN (NN-1530) Body Motion Sensor by Paramount Bed
2026-07-06 | Japan PMDA | Safety Communication | !! MEDIUM
Paramount Bed Co., Ltd. has initiated a Class II recall of its Nemuri SCAN (NN-1530) body motion sensor. The recall addresses a potential issue where the sensor may provide inaccurate movement detection, which could affect monitoring of patient sleep and activity. Healthcare facilities and users should stop using affected units and follow the manufacturer's instructions for return or replacement.
Tags: class_ii_recall, body_motion_sensor, paramount_bed, pmda, japan
Paramount Bed Recalls Nemuri SCAN (NN-1530) Body Movement Sensor – Class II
2026-07-06 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12874) for the Nemuri SCAN (NN-1530) body movement sensor, manufactured by Paramount Bed Co., Ltd. The recall addresses a potential malfunction that could result in inaccurate detection of patient movements, posing a moderate safety risk. Healthcare facilities and distributors should immediately check affected devices and contact the manufacturer to arrange inspection and necessary corrective actions.
Tags: pmda, recall, class_ii, body_movement_sensor, paramount_bed, sleep_scan
Swissmedic FSCA: Automated Impella Controller by Abiomed – Models 0042-0040, 0042-0010, 0042-0000 and variants
2026-07-06 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a field safety corrective action (FSCA) for the Automated Impella Controller (AIC) manufactured by Abiomed Inc. The affected devices are intracardiac circulatory assist axial-pump catheter control units with model numbers 0042-0040, 0042-0010, 0042-0000, and their EU/UK variants. While the specific reason is not detailed in the notice, users should consult the manufacturer’s instructions for the required corrective actions to ensure patient safety.
Tags: swissmedic, fsca, impella, heart_pump, abiomed, safety_alert, cardiac_assist
SFDA NCMDR Weekly Safety Update WU2628 Released for 5 July 2026
2026-07-05 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) has published Weekly Update WU2628, dated 5 July 2026. This report compiles recent medical device safety alerts and field safety corrective actions from manufacturers. Affected stakeholders include healthcare providers, distributors, and patients using the listed devices. All relevant parties should review the full report and implement any recommended actions promptly to ensure patient safety.
Tags: saudi_sfda, ncmdr_weekly, safety_alert, medical_devices
FDA Class I Recall: Insulet Removes Omnipod Pods Insulin Pump Due to Under-Delivery Risk
2026-07-03 | FDA | cdrh_news | !!! HIGH
The FDA has announced a Class I recall for Insulet's Omnipod Pods, used with the Omnipod DASH Insulin Management System, due to a missing cannula or needle that can result in under-delivery of insulin. This poses risks of hyperglycemia, diabetic ketoacidosis, and death. Patients and caregivers must immediately stop using affected lots, contact Insulet for replacements, and transition to an alternative insulin delivery method.
Tags: insulin_pump, class_I_recall, omnipod, diabetes_device, safety_alert, insulet
Abiomed Recalls Impella CP Sets with SmartAssist Due to Potential for Catheter Perforation
2026-07-03 | FDA | cdrh_news | !!! HIGH
Abiomed is recalling its Impella CP with SmartAssist sets after reports of the catheter tip breaking or perforating during insertion, which could lead to serious injury or death. The FDA has classified this as a Class I recall, the most serious type. Health care providers should immediately stop using affected devices and follow Abiomed's instructions for return and replacement. The recall affects certain lots distributed from August 2021 to March 2023.
Tags: recall, class_i, impella_cp, smartassist, heart_pump, abiomed, catheter_perforation
Health Canada Recalls Omni-Tract Surgical Retractor System Due to Sterility Failure
2026-07-03 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert regarding the Omni-Tract Surgical Retractor System after identifying a sterility failure that could lead to surgical site infections. Affected products include specific lots of the retractor system; healthcare facilities should immediately quarantine and stop using the devices. Users must follow the manufacturer's recall instructions for return or disposal to mitigate patient risk.
Tags: recall, sterility, surgical_instrument, health_canada
Health Canada recalls DLP Select 3D and Elongated One Piece Arterial Cannulae due to sterility performance issues
2026-07-03 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for specific DLP arterial cannulae due to potential sterility concerns that could compromise product performance. Affected devices include DLP Select 3D Arterial Cannula and DLP Elongated One Piece Arterial Cannulae. Healthcare facilities must immediately identify and quarantine affected inventory, discontinue use, and follow the manufacturer’s return or disposal instructions. This safety alert highlights a sterility failure that poses a risk of infection to patients.
Tags: canada_recall, sterility_failure, arterial_cannula, medical_device, safety_alert
Health Canada Recalls Hybrid Hydrophilic Microguidewire Due to Performance Issue
2026-07-03 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Hybrid Hydrophilic Microguidewire because of a performance defect. The issue may cause coating separation, wire fracture, or loss of hydrophilicity, potentially leading to vascular injury, embolism, or procedural failure. Healthcare professionals must immediately stop using the affected device, quarantine any inventory, and follow the manufacturer's recall instructions for return or replacement.
Tags: medical_device_recall, safety_alert, microguidewire, canada
Intramedullary Bone Saw Blade Assembly Recalled in Canada Due to Sterility Issues
2026-07-03 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Intramedullary Bone Saw Blade Assembly due to a lack of sterility assurance. The affected devices may not be sterile, posing a risk of infection to patients. Healthcare facilities must immediately quarantine and discontinue use of the impacted lots, and contact the manufacturer for return or replacement. This recall is part of a broader safety alert for medical devices.
Tags: medical_device_recall, sterility_issue, bone_saw_blade, health_canada, orthopedic_device
Health Canada Recalls Urinary Catheter Trays with Cliniclean Pericare Wipes Over Performance Concerns
2026-07-03 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for urinary catheter trays that contain Cliniclean Pericare Wipes due to performance deficiencies that may affect their intended cleaning and antiseptic function. Healthcare facilities and patients using these trays are affected. Users should immediately stop using the affected lots, quarantine the products, and contact the supplier for return and replacement.
Tags: medical_device_recall, catheter_tray, performance_issue, cliniclean, health_canada
[Class II] ジーシー ガスレーザー (炭酸ガスレーザ) - 株式会社ジーシー
2026-07-03 | Japan PMDA | Safety Communication | !! MEDIUM
Recall #2-12873: 炭酸ガスレーザ / ジーシー ガスレーザー by 株式会社ジーシー. Type: 医療機器.
Accuray CyberKnife Radiosurgery System and M6 Series Class II Recall in Japan (No. 2-12872)
2026-07-03 | Japan PMDA | Safety Communication | !! MEDIUM
Japan’s PMDA has issued a Class II recall (No. 2-12872) for the CyberKnife Radiosurgery System and CyberKnife M6 Series linear accelerator systems used in stereotactic radiotherapy, manufactured by Accuray Inc. The recall indicates a potential safety issue affecting these devices. Healthcare facilities in Japan operating these systems should immediately contact Accuray for corrective actions and follow the manufacturer’s instructions.
Tags: pmda_recall, class_ii, cyberknife, radiosurgery, linear_accelerator, stereotactic_radiotherapy, accuray
SFDA Hosts Workshops on Medical Device Clinical Trials and Health Tech at GHE
2026-07-03 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) organized two specialized workshops at the Global Health Exhibition (GHE) covering clinical trial requirements for medical devices and emerging healthcare technologies. The sessions targeted manufacturers, researchers, and healthcare professionals to enhance understanding of regulatory frameworks and encourage compliant innovation. Key discussions included trial design, ethical standards, and technology integration in the medical device sector.
Tags: clinical_trials, healthcare_technologies, sfda_workshop, medical_devices, regulatory_education
SFDA Signs MoU with AAMI to Enhance Medical Device Standards
2026-07-03 | Saudi SFDA | Regulation Update | !! MEDIUM
On July 18, 2023, the Saudi Food and Drug Authority (SFDA) signed a Memorandum of Understanding with the Association for the Advancement of Medical Instrumentation (AAMI) to collaborate on medical device standards. The partnership aims to align Saudi requirements with international best practices, affecting manufacturers seeking market access. Companies should monitor for forthcoming standards updates and guidance from this cooperation to ensure ongoing compliance.
Tags: medical_device_standards, SFDA, AAMI, regulatory_cooperation
SFDA Strengthens Global Standing by Regulating Clinical Studies for Innovative Medical Devices and Supplies
2026-07-03 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) is advancing its global regulatory position by organizing and overseeing clinical studies for innovative medical devices and supplies. This initiative aims to foster local clinical research, align with international best practices, and encourage medical device innovation within the Kingdom. Medical device manufacturers, clinical research organizations, and healthcare professionals involved in device trials will be directly affected as the authority reinforces its oversight framework.
Tags: clinical_studies, innovative_medical_devices, sfda, regulatory_oversight
Borderline products: MHRA guidance on determining if your product is a medicine
2026-07-02 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA guidance outlines the decision-making process for classifying products as medicinal products (medicines) versus medical devices or other categories. It covers essential criteria such as product presentation, pharmacological action, and intended purpose. Manufacturers of potentially borderline products should review this guide to ensure proper classification and comply with UK regulatory requirements, avoiding misclassification risks.
Tags: borderline_products, medicine_classification, mhra_guidance, product_classification, medical_device_regulation
Health Canada Alert: Performance Issue with Aisys, Avance, and Aespire Anesthesia Machines
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert regarding a performance issue affecting GE Healthcare's Aisys, Avance, and Aespire anesthesia machines. The recall addresses a potential malfunction that could compromise device performance during use. Healthcare facilities should immediately identify affected units, contact the manufacturer for corrective action, and ensure clinical contingency plans are in place until resolution.
Tags: medical_device_recall, anesthesia_machine, performance_issue, health_canada, safety_alert
Health Canada Issues Performance Alert for RAPIDLab® 348EX Blood Gas System
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert regarding the RAPIDLab® 348EX System, a blood gas analyzer, due to a performance issue that may lead to inaccurate test results. Laboratories and healthcare facilities using this device should immediately verify performance according to the manufacturer's instructions. The alert includes corrective actions to mitigate patient risks and ensure compliance.
Tags: medical_device_recall, performance_issue, blood_gas_analyzer, health_canada
Recall of AirSeal Access Port with Blunt Obturator and Optical Obturator Due to Performance Issue
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall for the AirSeal Access Port with Blunt Obturator and the AirSeal Access Port with Optical Obturator. The recall is due to a performance issue that could compromise device functionality during laparoscopic procedures. Healthcare facilities should immediately locate and quarantine affected units, and follow the manufacturer's instructions for return or disposal. This alert aims to prevent potential patient harm associated with the defective access ports.
Tags: medical_device_recall, laparoscopic_access_port, performance_issue, health_canada, safety_alert
Health Canada Recalls Glidesheath Slender® Introducer Sheath Due to Performance Issue
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Glidesheath Slender® Introducer Sheath (Terumo Corporation) due to a performance issue. The device may separate or kink during use, potentially causing vessel injury, prolonged bleeding, or delayed hemostasis. Affected lots must be immediately identified, quarantined, and returned to the manufacturer for replacement.
Tags: medical_device_recall, introducer_sheath, performance_defect
WASPLab Recall: Performance Issue May Impact Specimen Processing – Health Canada Alert
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall alert for the WASPLab automated microbiology system due to a performance issue that could lead to incorrect specimen processing or result errors. Healthcare facilities using affected WASPLab units should immediately verify system performance and follow the manufacturer's instructions. The recall aims to prevent potential misdiagnosis or delayed results. Users are advised to contact the manufacturer for corrective actions.
Tags: medical_device_recall, performance_issue, microbiology_automation, canada_health_alert
LIFECODES LSA Class II
2026-07-02 | Health Canada | Safety Communication | !! MEDIUM
Performance
Health Canada Recalls Fludeoxyglucose (18F) Injection Due to Cracked Vial, Risk of Contamination
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for Fludeoxyglucose (18F) Injection due to cracked vials, which pose a risk of compromised sterility and potential infection. This radiopharmaceutical is used in PET imaging, and affected healthcare facilities should immediately quarantine and return the impacted lots. The issue may lead to patient harm if the product is used without assured sterility. Further details on lot numbers and distribution can be found on the Health Canada recall page.
Tags: recall, radiopharmaceutical, product_quality, cracked_vial, health_canada
Health Canada Safety Alert: NephroMax High Pressure Nephrostomy Balloon Catheter Device Compatibility Issue
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert for the NephroMax High Pressure Nephrostomy Balloon Catheter due to a device compatibility issue. This recall affects all healthcare facilities using this catheter in nephrostomy procedures. Users are advised to check compatibility with guidewires and other accessories, and to report any incidents. The manufacturer is providing updated instructions for use.
Tags: recall, balloon_catheter, device_compatibility, safety_alert, health_canada
FSCA: B. Braun Infusomat Space P Single-Channel Infusion Pump (Model 8713070)
2026-07-02 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for the B. Braun Melsungen AG Infusomat Space P bedside infusion pump, model 8713070. The reason for the corrective action is not detailed in the brief notice, but it signals a potential safety issue requiring user attention. Healthcare facilities using this device should immediately consult the full FSCA on the Swissmedic portal and follow the manufacturer's recommended actions to mitigate any risk.
Tags: swissmedic, fsca, infusion_pump, safety, b_braun, field_safety_corrective_action
Class I Recall: Abiomed, Inc. - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 168 units of its Impella CP Set with SmartAssist (10th Generation) that contain the affected component 14. The recall was initiated due to the potential for thrombus formation during prolonged use of the introducer. Customers should immediately locate and quarantine the affected sets, discontinue use, and return them to Abiomed as instructed in the firm's Urgent Medical Device Recall notice.
Tags: class_i_recall, abiomed, impella_cp, thrombus, introducer
Abiomed Recalls Impella CP Low Profile Introducer Kit Due to Thrombus Risk – FDA Class I Recall
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. has initiated a Class I recall of its Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP, part of the Impella Set Pro, due to the potential for thrombus formation during prolonged use. The FDA has classified this as the most serious type of recall, indicating a risk of serious injury or death. A total of 17 units are affected. Healthcare providers should immediately stop using the recalled devices, quarantine them, and contact Abiomed for return instructions.
Tags: fda_class_i_recall, abiomed, impella_cp, introducer_kit, thrombus_risk, medical_device
Class I Recall: Abiomed 14 Fr Low Profile Introducer Kit for Impella CP – Thrombus Formation Risk
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling its 14 Fr x 13 cm Low Profile Introducer Kit (used with Impella CP/Impella Set Pro) due to a potential for thrombus formation during prolonged use. This Class I recall, the most serious type, involves only 3 units. Users should immediately quarantine the affected kits and follow the manufacturer’s instructions to prevent possible embolic events.
Tags: class_i_recall, thrombus_formation, impella_cp, abiomed, introducer_kit
Class I Recall: Medline Industries, LP - Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM
2026-07-01 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2452-2026 by Medline Industries, LP. Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality. Quantity: 227 units.
Class I Recall: Medline Industries, LP - Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE, Model Number: ACC0
2026-07-01 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2455-2026 by Medline Industries, LP. Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality. Quantity: 503 units.
Class I Recall: Medline Convenience Kit 'DRAWER 6 CENTRAL LINE INSERTIO' (ACC) with Recalled Lidocaine and Bupivacaine Injections
2026-07-01 | FDA | recall_class1 | !!! HIGH
Medline Industries, LP is recalling 233 units of its Convenience Kits (DRAWER 6 CENTRAL LINE INSERTIO, Model ACC) because they contain Arrow Kits with recalled Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP. The recalled anesthetic injections pose potential serious health risks due to quality defects, including infection, non-sterility, or adverse patient outcomes. This is a Class I recall, the most serious type. Healthcare providers must immediately stop using affected kits, quarantine them, and contact Medline for return or disposal instructions.
Tags: class_i_recall, medline, convenience_kits, lidocaine_recall, bupivacaine_recall, arrow_kits, drug_quality_defect
Class I Recall: Abiomed Impella CP Set with SmartAssist (10th Gen) Over Introducer Thrombus Risk
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. has issued a Class I recall for 7 units of the Impella CP Set with SmartAssist (10th Generation) due to a potential for thrombus formation during prolonged use of the introducer. This defect could lead to serious patient injury or death. Users should immediately quarantine and discontinue use of affected devices and follow the firm's recall instructions. Distribution was limited to a small number of facilities.
Tags: class_i_recall, impella_cp, thrombus_risk
MFDS Launches Innovative Medical Product Fast-Track Review with 240-Day Approval Target
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) of South Korea has introduced a new innovation-focused review pathway that aims to complete the approval of cutting-edge medical products within 240 days. This streamlined process targets high-tech medical devices and drugs, reducing regulatory turnaround time and enhancing predictability for sponsors. Manufacturers of innovative products should review the updated submission requirements and prepare for accelerated premarket reviews. The initiative reflects MFDS's commitment to expediting patient access to novel technologies.
Tags: fast_track, approval_timeline, innovation, mfds, regulatory_reform, premarket_review
MFDS Publishes Medical Device Good Manufacturing Practice (GMP) Regulations
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) has published the Medical Device Good Manufacturing Practice (GMP) Regulations, establishing quality management system requirements for manufacturers and importers. These regulations cover design, production, installation, and servicing standards to ensure device safety and performance. Stakeholders must align their quality systems with the new rules and prepare for compliance audits by MFDS. Companies distributing medical devices in Korea should review the full text and update their procedures accordingly.
Tags: gmp, quality_management_system, korea_mfds
MFDS Issues Guiding Principles for Clinical Trials of Machine Learning-Enabled Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) has published 'Guiding Principles for conducting Clinical Trial for Machine Learning-enabled MDs,' providing a regulatory framework for clinical evaluation of medical devices that incorporate machine learning. This guidance targets manufacturers and sponsors of ML-enabled medical devices, outlining key considerations for trial design, data management, performance assessment, and safety monitoring. Stakeholders are advised to review the principles to ensure their clinical trial protocols align with the new recommendations when seeking regulatory approval in Korea.
Tags: machine_learning, clinical_trial, guidance, medical_device, korea_mfds
MFDS Issues New Regulation on Unique Device Identification (UDI) Management for Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) has promulgated a new regulation establishing comprehensive requirements for Unique Device Identification (UDI) management. This rule mandates that medical device manufacturers, importers, and distributors assign and maintain UDI codes, register device identifiers in the integrated database, and comply with phased implementation timelines. The regulation aims to enhance traceability and safety across the device supply chain, requiring affected entities to update labeling, quality systems, and reporting processes accordingly.
Tags: unique_device_identification, udi, medical_device_regulation, korea_mfds, traceability
MFDS Guidance on Additional Considerations for Conformity Assessment of In Vitro Companion Diagnostic Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Ministry of Food and Drug Safety (MFDS) of Korea has published a guidance document specifying additional considerations for the conformity assessment of in vitro companion diagnostic medical devices. This affects manufacturers and sponsors of companion diagnostics by detailing supplementary evidence and performance requirements to be addressed during conformity assessment. Regulatory affairs professionals should review the new elements to ensure their technical documentation aligns with MFDS expectations when seeking or maintaining device approvals in Korea.
Tags: companion_diagnostics, ivd, conformity_assessment, mfds_guidance, korean_regulations
MFDS Amends the Enforcement Rule of the Medical Devices Act
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Ministry of Food and Drug Safety (MFDS) has revised the Enforcement Rule of the Medical Devices Act. This updated rule contains detailed administrative procedures covering device licensing, clinical investigations, good manufacturing practice, and post-market obligations. All medical device manufacturers, importers, and distributors operating in South Korea must review the changes and align their regulatory compliance processes accordingly. Industry should promptly assess the impact on product registrations, facility requirements, and reporting duties.
Tags: korea_mfds, medical_device_act, enforcement_rule, regulatory_update
MFDS Amends Regulation on Permission, Notification, Review of Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
This amendment updates the comprehensive Korean regulation governing medical device marketing authorization, notification, and review processes. It affects manufacturers and importers seeking to place devices on the Korean market, introducing revised procedures, documentation requirements, and classification criteria. Companies must review the changes to ensure ongoing compliance and adapt their registration dossiers accordingly.
Tags: korea, medical_device_regulation, marketing_authorization, review_procedure, notification
MFDS Issues Enforcement Rule of the Act on In-Vitro Diagnostic Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) has published the Enforcement Rule of the Act on In-Vitro Diagnostic Medical Devices, detailing the procedures and standards needed to implement the new IVD legislation in Korea. This rule applies to all manufacturers, importers, and distributors of in-vitro diagnostic products. Affected parties should review the rule to comply with requirements on classification, conformity assessment, quality management, and post-market surveillance.
Tags: korea_mfds, ivd_regulation, enforcement_rule, regulatory_update
MFDS Issues Instructions on Labeling and Management of Unique Device Identifiers
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) has released a guidance document specifying how medical device manufacturers and importers must label Unique Device Identifiers (UDIs) and manage UDI-related data. The instructions cover label placement, format, and submission requirements to the national UDI database. Affected companies should review and align their labeling and data management processes to meet Korea’s UDI compliance deadlines.
Tags: udi, labeling, medical_devices
MFDS Issues Regulations on Labeling and Description for Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The South Korean Ministry of Food and Drug Safety (MFDS) has published regulations detailing mandatory requirements for the labeling and description of medical devices marketed in Korea. These rules cover product identification, manufacturer information, intended use, warnings, and instructions, affecting all domestic and foreign manufacturers and importers. Companies must review their current labeling and descriptions to ensure full compliance with the updated provisions to avoid regulatory penalties or market access issues.
Tags: labeling, medical_device_regulation, korea_mfds, description_requirements, compliance
MFDS Revises Standards for Medical Device Good Manufacturing Practices (GMP)
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
South Korea's Ministry of Food and Drug Safety (MFDS) has published a revision to the Standards of Medical Device Good Manufacturing Practices. The updated standards align quality management system requirements more closely with international norms such as ISO 13485. Medical device manufacturers and importers in the Korean market must review their quality systems and implement necessary changes to remain compliant. A transition period is expected, and stakeholders should promptly assess the impact on their operations.
Tags: gmp, quality_management_system, korea_mfds, iso_13485, medical_device
MFDS Publishes 2025 Medical Device Approval Report
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Ministry of Food and Drug Safety (MFDS) has released its annual report detailing medical device approvals in Korea for 2025, covering certifications, amendments, and market trends. The report serves as a benchmark for manufacturers, importers, and regulatory professionals seeking to understand the Korean medical device approval landscape. No immediate regulatory action is required, but stakeholders are encouraged to review the data for strategic planning and compliance monitoring.
Tags: korea_mfds, medical_device_approval, annual_report, regulatory_affairs
MFDS Publishes 2024 Medical Device Approval Report
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Korean Ministry of Food and Drug Safety (MFDS) has issued its annual report for 2024, summarizing medical device approval statistics, including new certifications, amendments, and renewals. The document provides insights into approval volumes, review timelines, and product category trends. Regulatory professionals should examine the report to benchmark submission strategies and monitor shifts in MFDS review practices.
Tags: korea_mfds, medical_device_approval, annual_report, regulatory_intelligence
MFDS Publishes 2023 Medical Device Approval Statistics Report
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Ministry of Food and Drug Safety (MFDS) has released its Annual Medical Device Approval Report for 2023, summarizing the number of product approvals, certifications, and clearances. The data covers domestic and imported devices, providing industry stakeholders with insights into regulatory trends and market access activity. Medical device manufacturers and importers can use this information for benchmarking and strategic planning in the Korean market.
Tags: medical_device_approval, annual_report, MFDS, regulatory_statistics, South_Korea
MFDS Publishes 2022 Medical Device Approval Report with Market Trend Data
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Korean Ministry of Food and Drug Safety (MFDS) released the 2022 Medical Device Approval Report, providing annual statistics on approvals, certifications, and notifications. The report details trends by device class and product type, serving as a reference for manufacturers and regulatory professionals to understand Korea’s medical device market dynamics and plan market entry strategies.
Tags: medical_device, korea_mfds, approval_report, annual_statistics, regulatory_intelligence
MFDS Publishes 2021 Medical Device Approval Report and Statistics
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Korean Ministry of Food and Drug Safety (MFDS) released the 2021 Medical Device Approval Report, summarizing the year’s approval, certification, and amendment statistics. The report offers insights into approval volumes, timelines, and classification trends, helping regulatory affairs professionals assess market entry dynamics. No immediate compliance actions are required, but the data is valuable for strategic registration planning and benchmarking.
Tags: medical_device, approval_report, mfds, annual_statistics, korea_regulation
MFDS Publishes 2020 Medical Device Approval Report with Annual Statistics
2026-07-01 | Korea MFDS | Regulation Update | ! LOW
The Ministry of Food and Drug Safety (MFDS) has released its annual report on medical device approvals for 2020. The report provides a statistical overview of product registrations, certifications, and approvals, highlighting category trends and market entry volumes. Regulatory professionals and manufacturers can use this data to benchmark approval timelines, identify growth segments, and anticipate regulatory focus areas. No immediate action is required, but the document serves as a valuable resource for strategic planning and compliance monitoring.
Tags: medical_device_approval, mfds_report, market_statistics, 2020_annual_summary
MFDS Released the 2019 Medical Device Approval Report Summarizing Approval Statistics
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Korean Ministry of Food and Drug Safety (MFDS) published the 2019 Medical Device Approval Report, providing an overview of medical device approvals, certifications, and classifications for the year. This report is essential for medical device manufacturers, importers, and regulatory professionals to understand market access trends and regulatory activities in South Korea. It includes statistics on approval numbers, product categories, and review timelines, helping stakeholders assess the approval landscape and plan future submissions.
Tags: medical_device_approval, annual_report, korea_mfds
Swissmedic FSCA: Olympus Single Use Distal Cover (MAJ-2315) Patient Protection Cap
2026-07-01 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Olympus Single Use Distal Cover, a single-use endoscope patient protection cap. The affected model is MAJ-2315 and lot N6192000. While the specific reason for the corrective action was not detailed in the notification, users should immediately identify and quarantine affected products and follow Olympus' instructions to mitigate potential risks.
Tags: swissmedic, fsca, olympus, distal_cover
Swissmedic FSCA for SY-LAB IceCube Linear Rate Medical Freezers
2026-07-01 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for SY-LAB IceCube medical freezers with linear rate control, affecting models 11XS MED, 14S MED, 14M MED, 17M MED, 17L MED and their non-MED variants. The specific safety reason was not published in the initial notice. Users in laboratories and healthcare settings should immediately review the full FSCA on the Swissmedic portal and follow the manufacturer's corrective measures.
Tags: swissmedic, fsca, medical_freezer, laboratory_equipment, safety_correction
HSA Updates GN-21-R7 Guidance on Change Notification for Registered Medical Devices (Jul 2026)
2026-07-01 | Singapore HSA | Regulation Update | !! MEDIUM
Singapore's Health Sciences Authority (HSA) has released revision 7 of the GN-21 guidance document on change notification requirements for registered medical devices, effective July 2026. This update impacts all medical device license holders who need to report changes to their registered devices. Companies must review the revised criteria for notifiable changes, update their internal procedures, and ensure compliance by the effective date to avoid regulatory findings.
Tags: change_notification, hsa_guidance, medical_devices, singapore, post_market_compliance
EC Publishes Delegated Acts on Well-Established Technologies Under EU MDR
2026-06-30 | EU MDR/IVDR | Regulation Update | !!! HIGH
The European Commission has published new delegated acts concerning well-established technologies (WET) under the Medical Devices Regulation (MDR). This update affects manufacturers of specific Class IIb implantable and Class III devices, such as sutures, staples, and bone screws, by clarifying exemptions for clinical investigations. Affected manufacturers must review the updated acts upon entry into force to verify their eligibility for WET exemptions and adjust their clinical evaluation strategies accordingly.
Tags: eu_mdr, delegated_act, well_established_technologies, clinical_evaluation
View Source (European Commission)
FDA Title 21 CFR Update: Medical Device Parts 800-898 Revised (June 26, 2026)
2026-06-30 | FDA | Regulation Update | !! MEDIUM
The FDA has updated Title 21 of the Code of Federal Regulations (CFR), with the latest revision dated June 26, 2026. This update potentially affects medical device regulations under Parts 800-898. Regulatory affairs professionals should review the amended sections to ensure ongoing compliance for medical device manufacturing, labeling, and quality systems.
Tags: fda, cfr_title_21, medical_device_regulations
Boston Scientific Recalls Rapid Refill Continuous Injection System Due to Risk of Syringe Disconnection from Manifold
2026-06-30 | FDA | Safety Communication | !!! HIGH
The FDA announced a recall of Boston Scientific's Rapid Refill Continuous Injection System (UPN M00566001) because it contains a recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. The syringe may loosen or completely disconnect from the manifold, potentially causing therapy interruption, blood loss, or air embolism. Healthcare providers should immediately quarantine affected devices and follow Boston Scientific's recall instructions.
Tags: device_recall, fda_safety_alert, syringe_disconnection, boston_scientific, class_i_recall
Kent Imaging Recalls SnapshotGLO Wound Imaging Device Due to Battery Charging Failure
2026-06-30 | FDA | Safety Communication | !!! HIGH
Kent Imaging, Inc. is recalling its SnapshotGLO Wound Imaging Device (Models KB100, KB100AA) because the software controlling the battery charging circuit fails to recover a battery that has fully discharged into a low-power ‘shipping mode’. This prevents the device from recharging, leaving it inoperable when needed for wound assessment. Users should stop using the device if it does not charge and contact the manufacturer for a correction.
Tags: recall, battery_charging, wound_imaging, fda_safety_alert, medical_device
UK MHRA Publishes Field Safety Notices for 22–26 June 2026
2026-06-30 | UK MHRA | Safety Communication | !! MEDIUM
This item lists 10 field safety notices (FSNs) issued by medical device manufacturers during the week of 22–26 June 2026, as compiled by the UK MHRA. It alerts healthcare professionals, patients, and regulatory affairs teams to potential safety issues and required corrective actions. Affected parties should immediately review the notices, identify relevant devices, and implement any field safety corrective actions. The compilation is part of the MHRA's routine safety communication.
Tags: field_safety_notice, mhra, medical_device_safety
MHRA Safety Roundup – June 2026: Latest Safety Advice for Medicines and Medical Devices
2026-06-30 | UK MHRA | Safety Communication | !! MEDIUM
This June 2026 roundup from the UK MHRA consolidates the latest safety updates for both medicines and medical devices. Healthcare professionals, patients, and device users should review the listed warnings, recalls, and guidance to ensure continued safe use. The document highlights key actions including checking affected products and reporting adverse incidents through the Yellow Card scheme. It serves as a monthly compliance resource for vigilance and risk management.
Tags: mhra, safety_roundup, medical_devices, medication_safety, post_market_surveillance
MHRA Field Safety Notices compilation for 22–26 June 2026: 6 new device alerts published
2026-06-30 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA released a weekly list of six Field Safety Notices issued between 22 and 26 June 2026. Healthcare professionals and medical device organisations should review the notices to identify any relevant safety actions, such as software updates, part replacements, or usage modifications, and implement manufacturer instructions promptly to maintain patient safety and regulatory compliance.
Tags: field_safety_notice, mhra, medical_device_safety, regulatory_alert, postmarket_surveillance
FSCA for Medline MEDSTOP Stopcock: New Language Added to Labeling
2026-06-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a field safety corrective action for the MEDSTOP stopcock manufactured by Medline Industries LP. The corrective action involves adding a new language to the device labeling to meet regulatory requirements. Affected models are identified by their Field Safety Notice (FSN). Distributors and healthcare facilities should ensure the updated labeling is used.
Tags: stopcock, labeling_update, field_safety_corrective_action, medline, swissmedic
MHRA Issues Updated Guidance on Borderline Products: Medical Devices vs Other Products
2026-06-29 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has published updated guidance on borderline products, explaining the principles used to decide whether a product is a medical device and whether the Medical Devices Regulations 2002 apply. The document provides examples, flowcharts, and case studies to help manufacturers determine if their product falls under medicines, cosmetics, food, or general product safety regulations instead. Stakeholders should use this guidance to ensure correct classification and regulatory compliance in the UK market.
Tags: borderline_products, medical_device_classification, mhra_guidance, uk_regulations
Health Canada Safety Alert: Abiomed Introducer Kits with Impella Heart Pumps – Performance Issue
2026-06-29 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety recall/alert for specific Abiomed Introducer Kits used with Impella heart pumps due to a performance issue. The performance defect may impact device insertion, function, or patient safety during cardiac procedures. Affected healthcare facilities should immediately check the Health Canada alert, identify and quarantine the recalled lots, and follow the manufacturer’s instructions for return or disposal.
Tags: medical_device_recall, impella_heart_pump, performance_issue
Keynote Address by Adj Prof (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, on "Regulatory Innova
2026-06-29 | Singapore HSA | Regulation Update | !! MEDIUM
HSA Speeches: Keynote Address by Adj Prof (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, on "Regulatory Innovation as a Catalyst for Global Medtech Growth" for Singapore Medical Device Ventu
SFDA NCMDR Weekly Safety Update WU2627 – Medical Device Field Safety Notices and Recalls
2026-06-28 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) National Center for Medical Devices Reporting (NCMDR) published Weekly Update WU2627 on 28 June 2026, compiling new field safety corrective actions and recalls for medical devices. Healthcare facilities and distributors should review the listed devices and affected manufacturers to identify products requiring action and implement the recommended safety measures. The update covers multiple device categories and includes details on risk mitigation steps.
Tags: saudi_sfda, ncmdr, weekly_update, safety_notice, recall
MHRA Guidance: Registering Medical Devices for the Great Britain and Northern Ireland Markets
2026-06-26 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance outlines the process for registering medical devices before they can be placed on the market in Great Britain and Northern Ireland. It applies to manufacturers, authorised representatives, and responsible persons, who must ensure all devices are properly registered under the UK Medical Devices Regulations 2002. Key steps include identifying the correct registration route, submitting required device information, and maintaining compliance with post-market obligations. Failure to register can result in enforcement action and prevent lawful sale.
Tags: medical_device_registration, mhra, market_access, uk_compliance
[Alert] Product Alert of Dexcom US G7 Sensors: Lots 1725204004 and 1725069002
2026-06-25 | New Zealand Medsafe | Safety Communication | !! MEDIUM
Medsafe Alert - Product: Device
Argon Medical Devices L-Cath™ PICC and Midline Catheters Recall Due to Performance Issue
2026-06-24 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for Argon Medical Devices' L-Cath™ PICC and Midline Catheters due to a performance issue that may affect catheter function. The affected devices could pose risks such as catheter breakage, leakage, or failure during use, potentially leading to patient harm. Healthcare facilities should immediately identify and quarantine impacted lots, and follow the manufacturer's instructions for return or disposal.
Tags: canada_recall, picc_catheter, midline_catheter, performance_issue, argon_medical
Health Canada Issues Recall for UHI-4 High Flow Insufflation System Insufflator Due to Performance Problems
2026-06-24 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the UHI-4 High Flow Insufflation System Insufflator due to performance issues that may compromise device function. The recall affects all healthcare facilities using this insufflator in laparoscopic or endoscopic procedures. Users should immediately quarantine affected units, identify all stock, and contact the manufacturer for corrective actions. No adverse events have been confirmed at this time, but the device may present a risk to patient safety if performance degradation occurs during surgery.
Tags: medical_device_recall, insufflator, performance_failure, health_canada, surgical_safety
Health Canada Recalls Abbott's Infinion™ CX Contact Lead Kit Over Performance Concerns
2026-06-24 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Infinion™ CX Contact Lead Kit, a component of Abbott's spinal cord stimulation system, due to performance issues that may compromise device functionality. Affected products include all lots of the lead kit, which are used by healthcare providers to deliver neuromodulation therapy. The recall advises immediate identification and quarantine of unused kits, along with enhanced monitoring of patients already implanted with the lead. This alert is part of a broader update involving 10 new medical device recalls in Canada.
Tags: medical_device_recall, neuromodulation, lead_kit, performance_issue, canada_safety_alert
MHRA Field Safety Notices: 15-19 June 2026 – 10 New Notices Published
2026-06-23 | UK MHRA | Safety Communication | !! MEDIUM
This item aggregates 10 field safety notices issued by the UK MHRA between 15 and 19 June 2026. The notices cover various medical devices requiring corrective actions or safety communication from manufacturers. Healthcare providers and device manufacturers must review the list to identify affected products and implement any mandated actions to ensure patient safety and regulatory compliance.
Tags: field_safety_notices, mhra, medical_device_safety, post_market_surveillance, regulatory_compliance
UK MHRA Weekly Field Safety Notices Compilation: 15–19 June 2026
2026-06-23 | UK MHRA | Regulation Update | !! MEDIUM
This item lists all Field Safety Notices (FSNs) issued by the UK MHRA between 15 and 19 June 2026, covering post-market safety actions for medical devices and IVDs. It affects manufacturers, healthcare providers, and users who must review the notices for relevant corrective actions. Key actions include identifying affected devices in inventory, implementing manufacturer instructions, and reporting any incidents.
Tags: field_safety_notices, mhra, medical_device_safety
MHRA Decision: List of Medical Devices Granted Exceptional Use Authorisations
2026-06-23 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has published an updated list of manufacturers and medical devices that have been granted exceptional use authorisations. The list also includes devices whose exemptions have expired or been cancelled. Affected manufacturers, importers, and healthcare providers should review the list to verify the current status of relevant products and ensure continued compliance with the applicable conditions of the authorisation.
Tags: exceptional_use, mhra_authorisation, medical_devices, regulatory_update
Health Canada Recalls Hoffmann® II Carbon Connecting Rod Due to Performance Issue
2026-06-23 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Hoffmann® II Carbon Connecting Rod, an orthopaedic implant component, due to performance issues that may compromise device functionality and patient safety. Affected healthcare facilities and surgeons must immediately cease use of the recalled devices and follow the manufacturer's return or disposal instructions. This safety alert underscores the need for prompt inventory quarantine and adherence to adverse event reporting protocols.
Tags: medical_device_recall, performance_issue, orthopaedic_implant, health_canada
Recall of A.T.S® 4000 TS Tourniquet Systems with CPC Connectors Due to Sterility Concerns
2026-06-23 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for A.T.S® 4000 TS Tourniquet Systems single and dual hose models with CPC connectors. The recall is due to potential sterility issues that may compromise patient safety. Healthcare facilities using these devices should immediately identify affected units, discontinue use, and follow the manufacturer’s return or disposal instructions. This safety alert is part of a broader set of Canadian medical device recalls.
Tags: tourniquet, sterility, safety_recall, medical_device, canada
Health Canada Recalls Optima XR240amx X-Ray System Due to Performance Issue
2026-06-23 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Optima XR240amx X-Ray System due to a performance issue that may affect image quality or system reliability. Healthcare facilities using this device should immediately consult the recall notice and follow the manufacturer's corrective actions. Affected users must verify device status and may need to suspend use until remediation is completed. The alert is part of a wider set of medical device safety actions in Canada.
Tags: medical_device_recall, x_ray_system, canada
Health Canada Recalls CyberKnife® Treatment Delivery System Due to Performance Issues
2026-06-22 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the CyberKnife® Treatment Delivery System, manufactured by Accuray, due to performance issues that could lead to inaccuracies in radiation treatment delivery. Affected healthcare facilities must immediately follow the manufacturer's instructions for inspection, mitigation, and possible device repair or replacement. Users should contact the manufacturer to confirm if their system is impacted and implement necessary corrective actions to ensure patient safety.
Tags: medical_device_recall, radiation_therapy, performance_issue, canada, safety_alert
Health Canada Recalls Penumbra System RED 68 Reperfusion Catheter Due to Performance Issue Risking Tip Separation
2026-06-22 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall for the Penumbra System RED 68 Reperfusion Catheter due to a performance issue that may cause the catheter tip to separate or detach during use. The affected catheter is used in neurovascular thrombectomy procedures to remove blood clots from cerebral arteries. Healthcare professionals are advised to immediately quarantine and discontinue use of the recalled lots, and return them to Penumbra. This recall addresses a risk of serious adverse events, including vessel damage, embolism, or stroke.
Tags: medical_device_recall, performance_issue, catheter_tip_separation, neurovascular, class_i_recall, health_canada
Health Canada Recalls Gyrus ACMI Classic Series Continuous Flow Resectoscope Due to Sterility Issue
2026-06-22 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued an alert/recall for the Gyrus ACMI Classic Series Continuous Flow Resectoscope after a sterility issue was identified that could compromise device safety. Affected devices may not be sterile, posing an infection risk to patients during urological or gynecological procedures. Healthcare facilities should immediately quarantine the affected units, cease use, and follow the manufacturer's instructions for return or disposal. Prompt action is required to prevent potential patient harm.
Tags: medical_device_recall, sterility, resectoscope
SFDA NCMDR Weekly Update (WU2626) – Medical Device Safety Alerts and Adverse Event Reports
2026-06-21 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) released Weekly Update WU2626 through the National Center for Medical Devices Reporting (NCMDR), detailing recent safety alerts, adverse event reports, and field safety corrective actions concerning medical devices in the Saudi market. Healthcare providers, importers, and manufacturers should review the listed devices and implement any recommended actions to ensure patient safety and regulatory compliance.
Tags: medical_devices, safety_alert, sfda, ncmdr, weekly_update, saudi_arabia
Commission Implementing Decision (EU) 2026/1231 -- Updated Harmonised Standards for MDR
2026-06-17 | EU MDR/IVDR | Regulation Update | !!! HIGH
Published 17 June 2026 (effective 11 June 2026), this decision amends Decision 2021/1182 and updates harmonised standard references across nine medical device categories: biological evaluation (EN ISO 10993-12:2021/A1:2025), labelling/symbols (EN ISO 15223-1:2021/A1:2025), electromedical equipment, transfusion equipment, ophthalmic optics, non-active surgical implants, washer-disinfectors, prostheses, and sharps injury protection. Manufacturers must review technical documentation, declarations of conformity, and test reports against updated standard references.
Tags: harmonised_standards, biological_evaluation, labelling, conformity
Accuray CyberKnife Xchange Collimator Changer Recalled: Collimator Docking Failure May Cause Injury
2026-06-16 | FDA | Safety Communication | !!! HIGH
Accuray Incorporated is recalling its CyberKnife Treatment Delivery System with Xchange Robotic Collimator Changer due to a risk that a collimator may not fully dock. If personnel enter the treatment room and use the in-room control pendant after a docking interlock, the collimator could fall, posing a serious injury hazard. Users must follow the manufacturer's corrective actions, including not attempting manual motion when the interlock is active.
Tags: recall, radiation_therapy, collimator, safety, linear_accelerator, medical_device
Accuray CyberKnife with Xchange Collimator Changer Recalled for Collimator Docking Failure Hazard
2026-06-16 | FDA | Safety Communication | !!! HIGH
The FDA announced a recall of Accuray's CyberKnife Treatment Delivery System equipped with the Xchange Robotic Collimator Changer. If a collimator does not fully dock, a system interlock may be triggered; should personnel then manually move the robot using the in-room pendant, the collimator could fall, risking injury to patients or staff. Users should immediately inform all operators of this risk and adhere to the manufacturer's interim safety instructions until a permanent correction is deployed.
Tags: device_recall, radiation_oncology, collimator_failure, patient_safety, fda_recall
FARADRIVE Steerable Sheath: Swissmedic FSCA for Added Language to Labeling
2026-06-16 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for Boston Scientific's FARADRIVE Steerable Sheath, a single-use vascular guide-catheter. The reason is the addition of a new language to the product labeling, categorized as a correction. Affected models are referenced in the FSN; users should update and follow the revised instructions for use.
Tags: swissmedic, fsca, labeling_update, steerable_sheath, boston_scientific
Alerta 5265 (Tecnovigilância) - Comunicado da empresa Zimmer Biomet Brasil Ltda - Sutura MaxBraid.
2026-06-16 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5265 (Tecnovigilância) - Comunicado da empresa Zimmer Biomet Brasil Ltda - Sutura MaxBraid.
Alerta 5264 (Tecnovigilância) - Comunicado da empresa Olympus Optical do Brasil Ltda - Unidade de Insuflação de Alto Flu
2026-06-16 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5264 (Tecnovigilância) - Comunicado da empresa Olympus Optical do Brasil Ltda - Unidade de Insuflação de Alto Flu
Alerta 5263 (Tecnovigilância) - Comunicado da empresa Elekta Medical Systems Comércio e Serviços Radioterapia Ltda - Sis
2026-06-16 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5263 (Tecnovigilância) - Comunicado da empresa Elekta Medical Systems Comércio e Serviços Radioterapia Ltda - Sis
Alerta 5262 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Azurion (10216710345); Equipamento
2026-06-16 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5262 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Azurion (10216710345); Equipamento
Alerta 5261 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Arco Cirúrgico Zenition.
2026-06-16 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5261 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Arco Cirúrgico Zenition.
MHRA Weekly Field Safety Notices: 8-12 June 2026
2026-06-15 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA published the compilation of Field Safety Notices (FSNs) issued between 8 and 12 June 2026. These notices alert healthcare professionals and users to safety issues with medical devices and medicinal products, requiring actions such as product checks, modifications, or recalls. Manufacturers and responsible persons should review the list to identify any notices relevant to their products and ensure compliance with required actions. This weekly update is part of MHRA’s routine safety surveillance.
Tags: uk_mhra, field_safety_notice, safety_surveillance
Alerta 5260 (Tecnovigilância) - Comunicado da empresa GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hos
2026-06-15 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5260 (Tecnovigilância) - Comunicado da empresa GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hos
Alerta 5259 (Tecnovigilância) - Comunicado da empresa Randox Brasil LTDA - Controle de Urinálise.
2026-06-15 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5259 (Tecnovigilância) - Comunicado da empresa Randox Brasil LTDA - Controle de Urinálise.
Alerta 5258 (Tecnovigilância) - Comunicado da empresa Siemens Healthcare Diagnósticos Ltda - Reagente Flex Tacrolimus (T
2026-06-15 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5258 (Tecnovigilância) - Comunicado da empresa Siemens Healthcare Diagnósticos Ltda - Reagente Flex Tacrolimus (T
Alerta 5257 (Tecnovigilância) - Comunicado da empresa VR Medical Importadora e Distribuidora de Produtos médicos LTDA -
2026-06-15 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5257 (Tecnovigilância) - Comunicado da empresa VR Medical Importadora e Distribuidora de Produtos médicos LTDA -
SFDA NCMDR Weekly Safety Update WU2625 – 14 June 2026
2026-06-14 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) National Center for Medical Devices Reporting (NCMDR) has released Weekly Update WU2625 on 14 June 2026. This report contains recent adverse event notifications, field safety corrective actions, and recall notices for medical devices marketed in Saudi Arabia. Healthcare providers and device manufacturers should review the listed affected products and implement any required risk mitigation measures as specified in the update.
Tags: saudi_fda, ncmdr, medical_device_safety, weekly_report, recall_alert
Alerta 5256 (Tecnovigilância) - Comunicado da empresa Conmed do Brasil Comercio, Imp. e Exp. de Produtos Médicos Hospita
2026-06-12 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5256 (Tecnovigilância) - Comunicado da empresa Conmed do Brasil Comercio, Imp. e Exp. de Produtos Médicos Hospita
Recall: Zimmer Surgical Sterile Tourniquet Hoses (A.T.S 4000 TS) – Potential Sterility Breach (Recall Z-2673-2026)
2026-06-09 | FDA | Safety Communication | !!! HIGH
Zimmer Surgical has initiated a recall (Z-2673-2026) of its A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch. Use of affected devices could lead to moderate localized infection requiring treatment; if the issue is noticed before use, it may cause a clinically insignificant delay while an alternative device is obtained. Healthcare providers should immediately identify and quarantine all affected units, stop using them, and return them to the manufacturer as instructed.
Tags: device_recall, sterility_breach, tourniquet_hoses, zimmer_surgical
Zimmer Surgical Recalls A.T.S 4000 TS Tourniquet Single Hose Over Potential Sterility Breach
2026-06-09 | FDA | Safety Communication | !!! HIGH
The FDA has announced a recall of Zimmer Surgical's A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors (Recall Z-2674-2026) due to a potential sterility breach in the sealing area of the sterile pouch. If the affected device is used, it may lead to moderate localized infection; if discovered prior to use, it may cause a clinically insignificant extension of surgery while an alternative is sourced. Healthcare providers should immediately identify and quarantine all affected units.
Tags: recall, sterility_breach, tourniquet_hose, zimmer_surgical, infection_risk
FDA Recalls Siemens ARTIS icono ceiling Due to Risk of Monitor Detachment from Ceiling Suspension
2026-06-08 | FDA | Safety Communication | !!! HIGH
The FDA has issued a Class I recall (Z-2648-2026) for the Siemens ARTIS icono ceiling angiography system (model 11328100) due to a potential issue with the Display Ceiling Suspension (DCS Fix XL). Over time, screws securing the monitor to the suspension may gradually loosen, causing the monitor to detach and fall, posing a risk of impact injury to patients or healthcare staff. Affected facilities should immediately inspect the suspension assembly and contact Siemens to arrange for corrective maintenance.
Tags: fda_recall, siemens_medical_solutions, artis_icono_ceiling, ceiling_suspension, loose_screws, safety_alert
MHRA Field Safety Notices for 1–5 June 2026 Now Available
2026-06-08 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA has published the weekly list of Field Safety Notices (FSNs) for 1–5 June 2026. This compilation affects healthcare providers and organisations using affected medical devices in the UK. Users should review each notice and take recommended actions to address potential safety issues with specific devices.
Tags: field_safety_notice, mhra, medical_devices, uk_regulation, safety_alert
SFDA NCMDR Weekly Update WU2624 (07 June 2026) Issued
2026-06-07 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) has published Weekly Update WU2624 on 07 June 2026. This report summarizes recent medical device safety alerts, listing affected products and manufacturers. Healthcare providers and stakeholders should review the update to identify any necessary corrective actions or field safety notices relevant to their facilities.
Tags: saudi_fda, ncmdr, weekly_update, safety_alert
Medela Recalls ENFit ExSet Syringes Due to Incompatible Connectors Risking Enteral Feeding Delays
2026-06-05 | FDA | Safety Communication | !!! HIGH
Medela Inc. is recalling its ENFit ExSet Strl 60 2.0ml PV 1ct EN syringe (Model ENF060182LD / 101033086) because the product may contain incorrect connectors that cannot attach or misconnect to ENFit connections. This incompatibility could cause a slight delay in the delivery of enteral nutritional fluids or oral medication. Healthcare providers and patients should immediately identify affected units, discontinue use, and follow the firm's instructions for return or disposal.
Tags: recall, enteral_feeding, connector_safety, fda, medela
NMPA Announcement No. 56 (2026) -- Withdrawal of 10 Medical Device Industry Standards
2026-06-04 | NMPA | Standard Revision | !!! HIGH
Published 4 June 2026. NMPA withdraws 10 YY/T industry standards (transcatheter heart valves, anaesthetic/respiratory connectors and medical gas systems) and replaces them with corresponding GB/T national standards. Six standards are withdrawn on the announcement date; YY/T 0882-2013 on 1 July 2026; YY/T 0799-2010, YY/T 0801.1-2010 and YY/T 1439.2-2016 on 1 August 2026.
Tags: standards, abolished, YY, GB, nmpa
Device Recall: Remel, Inc - GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
2026-06-03 | FDA | Safety Communication | !! MEDIUM
Recall Z-2623-2026: Reduced or no recovery of some strains of Neisseria gonorrhoeae.
MDCG 2026-4: Management of SS(C)P in EUDAMED After Mandatory Use
2026-06-02 | EU MDR/IVDR | New Guidance | !!! HIGH
Published June 2026, MDCG 2026-4 transfers SSCP/SSP upload responsibility from Notified Bodies to manufacturers in EUDAMED. Key dates: from 28 May 2026 Notified Bodies continue uploading during transition; from October 2026 manufacturers take over direct upload; deadline 27 February 2027 for devices already on market. Manufacturers must upload master SS(C)P and translations, ensuring the uploaded version matches the one validated during certification.
Tags: eudamed, sscp, notified_body, manufacturer_obligation
View Source (European Commission)
NMPA Announcement No. 52 (2026) -- Medical Device Classification Adjustment Procedures
2026-06-01 | NMPA | Regulation Update | !!! HIGH
Published 1 June 2026, this announcement clarifies transitional procedures when medical device management categories or attributes are adjusted. Covers: registration/filing requirements when classification changes from higher to lower class; transition from medical device to non-medical device status; timeline and documentation requirements for affected manufacturers.
Tags: classification, registration, transition, compliance
Swissmedic FSCA: Armstrong Medical PEP Therapy APL Valve – Language Addition to Labeling
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic Field Safety Corrective Action (FSCA) concerns the APL Valve used in Positive Expiratory Pressure (PEP) Therapy Devices from Armstrong Medical Limited. The reason for the correction is the addition of a new language to the device labeling, likely to meet local regulatory language requirements. Affected models are listed in the Field Safety Notice (FSN). No direct patient safety issue is involved; users should follow the updated labeling instructions.
Tags: swissmedic, fsca, medical_device, labeling_update, pep_therapy, armstrong_medical, apl_valve
Swissmedic FSCA: Armstrong Medical Adult Coaxial Breathing Systems APL Valve - Added Language to Labeling
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic FSCA addresses Armstrong Medical Limited's Adult Coaxial Breathing Systems, specifically the APL valve. The corrective action adds a new language to the device labeling or instructions for use, ensuring compliance with Swiss official language requirements. Affected models are detailed in the related Field Safety Notice (FSN). Users should verify they have the updated labeling and follow the manufacturer's instructions.
Tags: swissmedic, fsca, breathing_system, armstrong_medical, labeling_update, apl_valve, language
Swissmedic FSCA: Armstrong Medical Resuscitation Sets (Mapleson Systems) – APL Valve Labeling Language Update
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic field safety corrective action addresses Armstrong Medical Limited's Resuscitation Sets (Mapleson Systems) where the APL valve labeling required a new language addition. Affected models are listed in the Field Safety Notice (FSN). Users are advised to consult the FSN and ensure the updated labeling is integrated into the instructions for use. This is a documentation correction, not a safety defect.
Tags: swissmedic, fsca, labeling_correction, resuscitation_set, armstrong_medical
Swissmedic FSCA: Paediatric Ayres T‑Piece Systems – APL Valve Label Updated with New Language
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Armstrong Medical Limited's Paediatric Ayres T‑Piece Systems (Resuscitation Set) affecting the APL Valve. The corrective action involves adding a new language to the device labelling to ensure proper use. Affected models are detailed in the Field Safety Notice (FSN); users should review the updated instructions and share the notice with relevant personnel.
Tags: swissmedic, fsca, medical_device, labeling_correction, pediatric_resuscitation, apl_valve
SFDA NCMDR Weekly Safety Update WU2622 (24 May 2026) Released
2026-05-24 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) has published Weekly Update WU2622, dated 24 May 2026. This report compiles recent field safety notices, recalls, and adverse event reports affecting medical devices registered in the Kingdom. Manufacturers, authorized representatives, and healthcare providers should review the listed alerts to identify any devices within their inventory and implement required corrective actions promptly.
Tags: sfda, ncmdr, weekly_safety_update, field_safety_notice, medical_device_recall
Swissmedic Expands °M Warmer FSCA: 7 More Lots Affected for MEQU A/S Blood/Fluid Warmer
2026-05-11 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has updated the Field Safety Corrective Action (FSCA) for MEQU A/S's °M Warmer, a conduction blood/fluid warmer, expanding the affected scope to include 7 additional lots. The correction applies to models MWS201 (Box of 5) and MWS201W (Single in Silver Pouch). Users should identify impacted devices and follow the manufacturer's instructions provided in the original FSCA notice.
Tags: swissmedic, fsca, blood_fluid_warmer, mequ, lot_expansion
Swissmedic FSCA: Staar Surgical AG IOD Software – New Information for Ophthalmology Instruments
2026-04-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for IOD Software, a software accessory manufactured by Staar Surgical AG used with various ophthalmology instruments. The corrective action stems from new information about the software, though affected model or lot details are not specified. Users of the impacted software should follow recommended actions such as applying updates or contacting the manufacturer to maintain safe and effective operation.
Tags: swissmedic, fsca, ophthalmology, software
FSCA Update for Maquet Cardiohelp II Base Unit (Model 701077135) – Change in Corrective Actions
2026-04-29 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action (FSCA) for Maquet Cardiopulmonary GmbH's Cardiohelp II Base Unit, a roller-type cardiopulmonary bypass system. This notice concerns a change in the corrective actions previously communicated for model 701077135. Affected users should review the updated instructions from the manufacturer and implement the revised measures to maintain device safety.
Tags: fsca, cardiopulmonary_bypass_system, corrective_action_update, swissmedic
Updated Safety Measures for ELEC plus Ceramic Ball Head Hip Component – ARTIQO GmbH
2026-04-27 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the ELEC plus Keramik-Kugelkopf (ceramic ball head), a femoral component of hip joint prostheses manufactured by ARTIQO GmbH. The FSCA communicates updated measures; specific affected models are listed in the manufacturer's Field Safety Notice. Healthcare facilities should immediately review the revised notice and implement the recommended actions to ensure patient safety.
Tags: hip_prosthesis, ceramic_ball_head, field_safety_corrective_action, swissmedic, medical_device_recall, arthroplasty
GN-02-R8 Annex 1 Declaration for dealing with MD that are solely for export or re-export purposes
2026-04-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-02-R8 Annex 1 Declaration for dealing with MD that are solely for export or re-export purposes (2026 Apr)
Swissmedic FSCA: Sphere-9 Catheter – Updated Field Safety Notice (Medtronic/BIOTRONIK)
2026-03-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for the Sphere-9 Catheter (Model AFR-00001), manufactured by Medtronic, Inc. and BIOTRONIK SE & Co. KG. The reason is a new version of the Field Safety Notice (FSN) for this cardiac tissue ablation device. Affected users should review the updated FSN and implement any revised instructions.
Tags: fsca, cardiac_ablation_catheter, field_safety_notice
NMPA Announcement No. 21 (2026) -- UDI Full Coverage Implementation Timeline
2026-03-13 | NMPA | Regulation Update | !!! HIGH
Published 13 March 2026, jointly issued by NMPA, National Health Commission and National Healthcare Security Administration. Mandates UDI implementation for all remaining medical device categories: all Class II devices and Class I IVDs by 1 June 2027; all Class I devices by 1 June 2029. Manufacturers must complete UDI assignment, data upload and maintenance. Provincial drug regulatory authorities are to coordinate with health and healthcare security departments to promote integration.
Tags: udi, traceability, full_coverage, multi_department
NMPA Announcement No. 15 (2026) -- UDI Exemption for Specific Circumstances
2026-03-13 | NMPA | Regulation Update | !! MEDIUM
Published 13 March 2026, defines 7 circumstances where medical devices are exempt from UDI implementation: clinical trial devices, custom-made devices, device components, post-market study devices, and others. For reusable devices where direct marking may affect safety, UDI must be marked on the smallest sales unit packaging with alternative traceability solutions.
Tags: udi, exemption, clinical_trial, custom_device
Swissmedic FSCA: Vue PACS Additional Software Versions Affected
2026-03-11 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has updated a field safety corrective action for Philips Medical Systems Nederland B.V. Vue PACS radiological software (model 1017979). The update includes additional software versions now affected by the issue. Users should review the manufacturer's notice and apply any required software updates or mitigations.
Tags: fsca, swissmedic, vue_pacs, philips, radiology_software, product_correction
GN-15-R13 Guidance on Medical Device Product Registration
2026-03-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-15-R13 Guidance on Medical Device Product Registration (2026 Mar)
FDA Revised Cybersecurity Guidance for Medical Devices (Feb 2026)
2026-02-03 | FDA | New Guidance | !!! HIGH
Issued 3 February 2026, superseding the June 2025 version. Aligns with the new QMSR and ISO 13485. Applies to all devices with cybersecurity considerations, not just network-connected devices. Key expectations: Secure Product Development Framework (SPDF), threat modeling, Software Bill of Materials (SBOM), eight security control categories (authentication, authorization, cryptography, integrity, confidentiality, event detection, resiliency, updatability), and coordinated vulnerability disclosure processes.
Tags: cybersecurity, premarket_submission, software, sbom
QMSR Takes Effect -- 21 CFR Part 820 Incorporates ISO 13485:2016
2026-02-02 | FDA | Regulation Update | !!! HIGH
Effective 2 February 2026, the FDA's Quality Management System Regulation (QMSR) amends 21 CFR Part 820 by incorporating ISO 13485:2016 by reference. The legacy Quality System Inspection Technique (QSIT) was discontinued and replaced by Compliance Program 7382.850, aligned with ISO 13485. Manufacturers must now explicitly comply with ISO 13485:2016 requirements. Two older guidance documents (1997 design control guidance and 2008 PMA manufacturing inspection guidance) were withdrawn.
Tags: quality_management, iso_13485, cgmp, inspection
Follow-up Field Safety Notice for ORBIS Medication 3.x by DH Healthcare GmbH
2026-01-23 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a follow-up Field Safety Corrective Action (FSCA) for ORBIS Medication 3.x, a medical device software from DH Healthcare GmbH. This notice provides additional information supplementing previously issued Field Safety Notices (FSNs). Affected model numbers are not specified in the notice. Users should review the updated safety information and follow the manufacturer’s recommendations.
Tags: swissmedic, fsca, field_safety_notice, follow_up, medical_device_software, dh_healthcare, orbis_medication
Zimmer Tourniquet Systems: Field Safety Corrective Action for Serial Number Update (Models 60500010100, 60320010100)
2026-01-20 | Swissmedic | Safety Communication | !! MEDIUM
Zimmer Surgical, Inc. has issued a Field Safety Corrective Action (FSCA) for the Zimmer Tourniquet Systems concerning models 60500010100 and 60320010100. The reason is to update serial numbers, which may involve correcting records or labeling to maintain traceability. Affected users should follow the manufacturer’s instructions to verify and update the serial numbers as required.
Tags: swissmedic, fsca, tourniquet_system, serial_number_update, zimmer_surgical
Zimmer Tourniquet Systems Serial Number Update – Swissmedic FSCA
2026-01-20 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a Field Safety Corrective Action for Zimmer Surgical's pneumatic tourniquet systems (models 60500010100, 60320010100). The corrective action is to update serial numbers, likely due to labeling or documentation discrepancies. Affected users should follow manufacturer instructions to verify and update the serial numbers; no product recall or return is required.
Tags: swissmedic, fsca, zimmer_surgical, tourniquet_system, serial_number_update
Philips Azurion System FSCA: Additional Language Versions of Field Safety Notice V2
2025-12-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action (FSCA) for Philips Medical Systems Nederland B.V. concerning stationary angiographic X-ray systems Azurion (models 722229–722236). The action is a product correction where Philips added new language versions for the existing Field Safety Notice (FSN V2) to improve distribution. No defect or safety risk is involved; affected users should note the updated notice availability.
Tags: fsca, philips, angiographic_system, field_safety_notice, swissmedic
GL-04-R4 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach
2025-12-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GL-04-R4 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2025 Dec)
GN-34 R2 Guidance for IVD Analysers
2025-10-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-34 R2 Guidance for IVD Analysers (2025 Oct)
GN-17 R4 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT
2025-10-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-17 R4 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (2025 Oct)
GN-18 R4 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT
2025-10-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-18 R4 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2025 Oct)
GL-08-R2 Regulatory Guidelines for Laboratory Developed Tests (LDTs)
2025-09-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GL-08-R2 Regulatory Guidelines for Laboratory Developed Tests (LDTs) (2025 Sep)
Medin-NC3 Neonatal CPAP Unit: New Blower and Software Update Available – Swissmedic FSCA
2025-08-15 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action for the Medin-NC3 neonatal CPAP unit (model 3000) from medin Medical Innovations GmbH. The manufacturer is making a new blower and a software update available to improve device performance or safety. Users should contact the manufacturer to schedule the correction.
Tags: swissmedic_fsca, neonatal_cpap, product_correction
[Alert] Stop using Euky Bear Warm Steam Vaporiser - model number EBSV2013
2025-05-30 | New Zealand Medsafe | Safety Communication | !! MEDIUM
Medsafe Alert - Product: Device