Health Canada Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Health Canada Alert: PERMA-HAND™ Silk Suture Recall Due to Performance Issue
2026-09-25 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for PERMA-HAND™ Silk Suture due to a performance issue. This affects healthcare facilities and providers using the affected suture product in Canada. Users should review the notice for affected lot information, discontinue use as directed, and follow the manufacturer's recall and reporting instructions.
Tags: health_canada, suture, performance_issue, medical_device_recall
Health Canada Recall: Amplatzer™ Amulet™ Left Atrial Appendage Occluder – Labelling and Packaging
2026-09-25 | Health Canada | Safety Communication | !!! HIGH
Health Canada has posted a medical device recall/alert for the Amplatzer™ Amulet™ Left Atrial Appendage Occluder due to labelling and packaging issues. The notice affects healthcare facilities and professionals that stock or implant this device. Affected parties should review the recall notice, identify affected lots, and follow the manufacturer’s and Health Canada’s instructions for quarantine, return, or corrective action.
Tags: medical_device_recall, labelling_packaging, left_atrial_appendage_occluder, health_canada
Limited number of Sarclisa single use vials may have been frozen during shipment
2026-09-25 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a product quality alert concerning a limited number of Sarclisa (isatuximab) single-use vials that may have been frozen during shipment. Freezing can compromise the quality and effectiveness of the product. Healthcare professionals and distributors should check shipment records, quarantine any suspect vials, and follow the manufacturer’s or Health Canada’s instructions for reporting and disposal.
Tags: product_quality, cold_chain, recall_alert
Sanofi-Aventis Canada Recalls Certain Insulin Pens and Cartridges
2026-09-25 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall alert for certain insulin pens and cartridges distributed by Sanofi-Aventis Canada Inc. The alert applies to specific affected lots; patients and healthcare providers should check the recall notice to identify whether their products are included. Users with affected devices should contact Sanofi-Aventis Canada or their healthcare provider for return/replacement and to ensure continuity of insulin therapy.
Tags: insulin_pen, medical_device_recall, health_canada
Health Canada Alert: Medtronic InterStim™ Systems Device Compatibility Issue
2026-09-24 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for Medtronic InterStim™ Systems due to a device compatibility issue. The alert affects certain InterStim™ implantable neurostimulation systems and related components distributed in Canada. Healthcare providers should identify affected devices and follow the manufacturer's field action instructions, while patients should contact their clinician for guidance.
Tags: medical_device_recall, device_compatibility, neuromodulation, health_canada, medtronic_interstim
Health Canada Recall: Likorall™ Patient Lift Systems – Performance Issue
2026-09-24 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall/alert for Likorall™ Patient Lift Systems due to a performance issue. The affected devices are patient lift systems used to transfer patients in healthcare and home care settings. Users should consult the Health Canada notice and manufacturer instructions for inspection, maintenance, or discontinuation of affected units as appropriate.
Tags: medical_device_recall, patient_lift, performance_issue, health_canada
Health Canada Safety Alert: Inzone® Detachment System Performance Issue
2026-09-24 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a safety alert/recall concerning the Inzone® Detachment System due to a performance issue. Healthcare providers and facilities using this device should review the notice, identify affected units, and follow the manufacturer’s or Health Canada’s recommended actions. The alert is part of the latest Canadian medical device recall updates and may require quarantine or return of affected product.
Tags: medical_device_recall, health_canada, performance_issue, safety_alert
Health Canada Alert: OmniaSecure™ MRI SureScan™ Performance Recall
2026-09-23 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for OmniaSecure™ MRI SureScan™ due to a performance issue. This affects patients implanted with this cardiac lead and the healthcare providers managing them. Affected facilities should identify and track patients, follow the manufacturer's corrective action, and monitor for potential lead performance problems.
Tags: medical_device_recall, cardiac_lead, performance_issue, mri_conditional
Health Canada Recall: Williams Cystoscopic Injection Needle – Performance Issue
2026-09-23 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the Williams Cystoscopic Injection Needle due to a performance issue. The device is used in cystoscopic injection procedures; affected units may fail to perform as intended, potentially leading to procedural complications or patient harm. Healthcare professionals and facilities should immediately identify and quarantine affected lots, discontinue use, and follow the manufacturer’s recall instructions.
Tags: medical_device_recall, cystoscopic_injection_needle, performance_issue
IMAAVY: Affected Lots May Contain Glass Particles
2026-09-21 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall alert for specific lots of the medical device IMAAVY because they may contain glass particles. Healthcare professionals and facilities should check inventory for affected lot numbers, quarantine the product immediately, and follow the manufacturer's recall instructions. Use of affected lots could pose a risk of particulate exposure or injury.
Tags: medical_device_recall, glass_particles, product_quality
Health Canada Issues Recall Alert for GE SIGNA™ Artist and SIGNA™ Artist Evo MRI Systems Due to Performance Issue
2026-09-18 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall/alert for GE HealthCare's SIGNA™ Artist and SIGNA™ Artist Evo magnetic resonance imaging (MRI) systems due to a performance concern. Healthcare facilities operating these systems are affected. Users should review the Health Canada notice, contact GE HealthCare for corrective action, and follow any recommended workarounds or servicing.
Tags: health_canada, medical_device_recall, mri_safety, performance_issue
Health Canada Alert: Philips Ingenia, Achieva and Intera MR Systems – Performance Issue
2026-09-17 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for Philips Ingenia, Achieva and Intera MR systems due to a performance issue. This affects healthcare facilities and imaging departments using these MRI systems. Affected users should review the Health Canada notice and Philips field action instructions and implement any required corrective actions or monitoring.
Tags: health_canada, medical_device_recall, mri_safety, philips, performance_issue
Health Canada Alert: Trinity Biotech Oxalate Reagent Kit Recall Due to Performance Issue
2026-09-17 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the Trinity Biotech Oxalate Reagent Kit due to performance concerns. This in vitro diagnostic product may produce unreliable oxalate measurements, potentially affecting patient results and clinical decisions. Affected laboratories and healthcare facilities should verify inventory, discontinue use as directed, and follow manufacturer or Health Canada instructions for return or replacement.
Tags: recall, ivd, performance_issue, health_canada
Health Canada Safety Alert: RAPICIDE™ PA High Level Disinfectant Performance Concern
2026-09-17 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for RAPICIDE™ PA High Level Disinfectant due to a performance issue. Healthcare facilities using this product for high-level disinfection of medical devices may be affected, with potential risk that disinfection efficacy could be compromised. Users should review the Health Canada notice, follow any recommended corrective actions, and verify recent disinfection processes according to facility protocols.
Tags: medical_device_recall, high_level_disinfectant, disinfection_efficacy
Platinum Naturals Easymulti Stress (men): Incorrect Vitamin B6 Quantity Labelling on Affected Lots
2026-09-16 | Health Canada | Safety Communication | !! MEDIUM
Health Canada has issued a labelling alert for Platinum Naturals Easymulti Stress (men) because affected lots are incorrectly labelled for Vitamin B6 quantity. Consumers and retailers should check product lot numbers against the recall notice and stop using or distributing the affected lots. Regulatory affairs professionals should review labelling compliance and screen inventory for the mislabelled product.
Tags: labelling_error, recall, health_canada
Canada Recall: NDI Passive Spheres™ Performance Alert
2026-09-16 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall/alert for NDI Passive Spheres™, optical tracking markers used in surgical navigation and image-guided procedures, due to a performance issue. Healthcare facilities using these spheres should identify affected lots, quarantine the devices, and contact the manufacturer or distributor for corrective action. The performance defect may affect tracking accuracy and could impact procedural safety, so users should follow the alert instructions and monitor for navigation deviations.
Tags: medical_device_recall, surgical_navigation, performance_issue
Health Canada Recall Alert: IntelliSpace Critical Care and Anesthesia Performance Issue
2026-09-16 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall/alert for Philips IntelliSpace Critical Care and Anesthesia due to a performance-related issue. Healthcare facilities using the affected software may be impacted by impaired system performance or reliability. Affected users should review the Health Canada notice, identify installed versions, and follow Philips' recommended mitigations or updates.
Tags: medical_device_recall, health_canada, clinical_software, performance_issue
Organika® Gummies: Foreign Site Not Listed on Site Licence
2026-09-15 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued an alert for Organika® Gummies because the product was manufactured at a foreign site that is not listed on the Canadian site licence. Importers, distributors, and retailers in Canada are affected and should verify their inventory against the notice; affected lots may need to be removed from sale. Consumers who purchased Organika® Gummies should check the recall notice for batch/lot details and discontinue use of any affected product. The alert highlights the need to verify foreign site licensing before importation.
Tags: canada_recall, establishment_licensing, foreign_site_compliance
Health Canada Alert: IMN Screws System Advanced Locking Screw Device Compatibility Issue
2026-09-10 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the IMN Screws System Advanced Locking Screw due to a device compatibility concern. Healthcare facilities and users should check affected lots, quarantine incompatible units, and follow the manufacturer's field action or recall instructions. This issue may affect surgical procedures using the IMN system and requires inventory verification.
Tags: health_canada, medical_device_recall, device_compatibility, orthopedic_implants
Health Canada Recall Alert: DxC 500i and DxC 500 AU Clinical Chemistry Analyzers – Performance Issue
2026-09-10 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the DxC 500i Clinical Analyzer and DxC 500 AU Clinical Chemistry Analyzer due to a performance issue. Laboratories and healthcare facilities using these analyzers are affected. Users should review the recall notice, follow the manufacturer's corrective actions, and implement any recommended performance verification or mitigation measures to ensure accurate clinical chemistry results.
Tags: medical_device_recall, clinical_chemistry_analyzer, performance_issue
Health Canada Recall: Centricity High Acuity Anesthesia Performance Issue
2026-09-10 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for Centricity High Acuity Anesthesia due to a performance issue. Healthcare facilities using this anesthesia information system may be affected by unreliable device performance. Affected users should review the recall notice and contact the manufacturer or Health Canada for corrective actions.
Tags: health_canada, medical_device_recall, anesthesia_software, performance_issue
Health Canada Recall/Alert: Philips Ingenia, Achieva and Intera MR Systems Performance Issue
2026-09-09 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a medical device recall/alert for Philips Ingenia, Achieva and Intera MR systems due to a performance issue. Healthcare facilities using these MRI models are affected. Users should review the Health Canada notice and the manufacturer's field safety notice, follow recommended safety measures, and contact Philips Canada for corrective action or additional information.
Tags: health_canada, mri_systems, medical_device_recall, performance_issue
Health Canada Recall: Veradius Unity and BV Pulsera Mobile C-Arm Systems (9in. and 12in.)
2026-09-09 | Health Canada | Safety Communication | !!! HIGH
This Health Canada safety alert/recall concerns a performance issue with the Veradius Unity and BV Pulsera Mobile C-Arm Systems, 9-inch and 12-inch versions. Healthcare facilities using these mobile C-arm imaging systems are affected. Users should review the recall notice and follow manufacturer-recommended corrective actions, including any inspection, testing, or use restrictions.
Tags: health_canada, medical_device_recall, mobile_c_arm
Health Canada Updates Forms for Exceptional Importation and Sale of Medical Devices
2026-09-07 | Health Canada | Regulation Update | !! MEDIUM
Health Canada has published a compliance bulletin announcing updated forms for the exceptional importation and sale of medical devices. Stakeholders seeking authorization under the Medical Devices Regulations must use the revised forms. Manufacturers, importers, and distributors involved in exceptional access to medical devices should review the bulletin and update internal procedures to replace prior form versions.
Tags: medical_devices, exceptional_importation, health_canada, compliance_bulletin, forms
Health Canada Recall: Imager™ II Angiographic Catheter – Performance Issue
2026-09-04 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a recall/alert for the Imager™ II Angiographic Catheter due to a performance issue. The notice applies to Canadian healthcare facilities and staff using this angiographic catheter in interventional procedures. Affected users should identify and quarantine any impacted units, consult the recall notice for affected lot or serial information, and follow the manufacturer’s or Health Canada’s instructions for return or replacement.
Tags: medical_device_recall, angiographic_catheter, health_canada
Health Canada Issues Recall for GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Due to Performance Issue
2026-09-04 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive surface due to a performance issue. Healthcare providers using this vascular endoprosthesis should identify affected inventory and stop using recalled devices. Facilities should quarantine and return affected product according to the manufacturer's instructions and follow any recommended patient monitoring or follow-up actions.
Tags: medical_device_recall, vascular_endoprosthesis, performance_issue
Health Canada Alert: Stryker LIFEPAK 35 Monitor/Defibrillator Performance Issue
2026-09-04 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the Stryker LIFEPAK 35 Monitor/Defibrillator due to a performance issue. This affects healthcare providers and emergency responders who use the device for monitoring and defibrillation. Affected facilities should identify and quarantine affected units, consult the recall notice, and follow Stryker’s recommended corrective actions immediately.
Tags: medical_device_recall, defibrillator, health_canada, performance_issue
Canada Recall: Quantum PureFlow Standard Heat Exchanger High Flow – Sterility Issue
2026-09-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall/alert for the Quantum PureFlow Standard Heat Exchanger High Flow due to a sterility concern. The affected device may not meet sterility requirements, posing a potential infection risk to patients during clinical use. Healthcare facilities should identify and quarantine affected units, stop use, and follow the manufacturer's recall instructions and Health Canada guidance.
Tags: medical_device_recall, sterility, heat_exchanger, health_canada, infection_risk
Health Canada Recall Alert: BiCOAG Hemostasis Probe – Performance Issue
2026-09-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the BiCOAG Hemostasis Probe due to a performance issue that may affect its hemostasis function. Healthcare facilities and users should identify affected units, quarantine or discontinue use as directed, and follow the manufacturer’s recall instructions. This is part of recent Canadian medical device safety actions.
Tags: medical_device_recall, health_canada, hemostasis_probe
Health Canada Recall: LEO+ Intracranial Self-Expandable Stent and Delivery System – Performance Issue
2026-09-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall/alert for the LEO+ Intracranial Self-Expandable Stent and Delivery System due to a performance issue. The device is used in neurovascular procedures, and the alert is directed at healthcare facilities and professionals that use or stock this system. Regulatory affairs teams should review inventory, quarantine affected units, and follow Health Canada’s recall notice for return or correction actions.
Tags: medical_device_recall, intracranial_stent, performance_issue, health_canada, neurovascular
Health Canada Recall Alert: LIFEPAK 35 Monitor/Defibrillator Performance Issue
2026-09-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall alert for the LIFEPAK 35 Monitor/Defibrillator due to a performance issue. This alert affects Canadian healthcare facilities and emergency medical services that use the device for patient monitoring and defibrillation. Users should immediately review the recall notice and follow the manufacturer's recommended actions, including inspection, mitigation, or discontinuation as advised.
Tags: medical_device_recall, defibrillator, performance_issue, health_canada
Health Canada Notice: Changes to Special Access Program Medical Device Application Process
2026-08-31 | Health Canada | Regulation Update | !! MEDIUM
Health Canada has issued a notice describing new changes to the application process for the Special Access Program (SAP) for medical devices. The changes affect manufacturers, importers, and health care practitioners seeking access to unlicensed medical devices for emergency or special needs. Applicants should review the updated requirements and adjust their submissions to the revised process to avoid delays or non-compliance.
Tags: health_canada, special_access_program, medical_devices, application_process, regulatory_change
Health Canada Guidance on the Regulatory Enrolment Process for Medical Devices
2026-08-31 | Health Canada | Regulation Update | !! MEDIUM
Health Canada has issued guidance outlining the regulatory enrolment process for medical devices. The document covers procedural steps, application format, data requirements, and submission expectations for enrolling devices with Health Canada. Medical device manufacturers, sponsors, and regulatory affairs professionals planning to market devices in Canada should review the guidance and align their submissions accordingly. Key actions include confirming the applicable enrolment pathway and ensuring the required information is complete and compliant.
Tags: health_canada, medical_device_registration, regulatory_enrolment
Health Canada Mandates Regulatory Enrolment Process for Medical Devices
2026-08-31 | Health Canada | Regulation Update | !!! HIGH
Health Canada has issued a notice to industry announcing that use of the Regulatory Enrolment Process (REP) is now mandatory for medical devices. Medical device manufacturers, importers, and other regulatory stakeholders must use this process for applicable regulatory submissions and transactions. This change introduces a mandatory enrolment step to streamline and standardize medical device regulatory activities. Stakeholders should review the notice and update their submission procedures accordingly.
Tags: health_canada, medical_devices, regulatory_enrolment_process
Health Canada Guidance: New Medical Device Licence or Amendment Application for Private Label Devices
2026-08-31 | Health Canada | Regulation Update | !! MEDIUM
Health Canada has issued guidance on completing applications for a new medical device licence or an amendment for private label medical devices. It is intended for manufacturers, private labelers, and importers/distributors who need to submit or amend a private label medical device licence. The document outlines required information, application steps, and supporting documentation. Affected parties should review the guidance before preparing submissions to Health Canada.
Tags: private_label, medical_device_licence, guidance_document, health_canada
Health Canada Guidance: Completing Applications for New or Amended Medical Device Licences
2026-08-31 | Health Canada | Regulation Update | !! MEDIUM
This Health Canada guidance explains how to complete the application form for a new or amended medical device licence under the Medical Devices Regulations. It applies to manufacturers, importers, and regulatory affairs professionals preparing Class II, III, or IV device licence submissions. Affected parties should review the updated instructions carefully to ensure complete, accurate applications and help prevent processing delays.
Tags: health_canada, medical_device_licence, regulatory_submission, guidance
Health Canada Alert: Carestation 850 Anesthesia Workstation Performance Recall
2026-08-28 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a recall/safety alert for the Carestation 850 anesthesia workstation due to a performance issue. Healthcare facilities using this device should verify whether their units are affected and follow the manufacturer’s corrective actions. Users should monitor device performance and report any malfunctions to the manufacturer and relevant regulatory authorities.
Tags: medical_device_recall, anesthesia_workstation, performance_issue
Health Canada Alert: pro+ Flat Deck Wide W/O X-Ray Device Compatibility Recall
2026-08-27 | Health Canada | Safety Communication | !!! HIGH
This Health Canada safety alert addresses a device compatibility issue involving the pro+ Flat Deck Wide W/O X-Ray. Affected users and healthcare facilities should verify whether their device configuration is compatible with the intended use and review manufacturer communications. Discontinue use of incompatible combinations and contact the manufacturer or Health Canada for guidance.
Tags: health_canada, medical_device_recall, device_compatibility, safety_alert
Health Canada Recalls Cardinal Health Gynaecology Robotics and Endoscopy Packs Over Performance Issue
2026-08-27 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for Cardinal Health Gynaecology Robotics and Endoscopy Packs due to a performance issue. Healthcare facilities using these packs for gynaecological robotic or endoscopic procedures are affected. Users should identify and quarantine affected lots, stop use, and follow Cardinal Health's recall instructions. Regulatory affairs teams should verify inventory and document field action responses.
Tags: medical_device_recall, health_canada, gynecology_endoscopy_packs
Health Canada Safety Alert: Automated Impella Controller (AIC) Performance Issue
2026-08-27 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a medical device alert/recall for the Automated Impella Controller (AIC) related to a performance issue. Healthcare facilities and professionals using this controller with Impella heart pumps are affected. Affected users should review the Health Canada notice and follow the manufacturer's recommended actions, including monitoring and contacting the manufacturer if needed.
Tags: medical_device_recall, cardiac_assist_device, safety_alert
Maquet Percutaneous Insertion Kit and Dilator Sets Recalled Due to Sterility Issue
2026-08-26 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall/alert for Maquet Percutaneous Insertion Kit and Dilator Sets due to sterility concerns that may compromise product sterility and pose an infection risk. Healthcare facilities using these kits and dilator sets should immediately identify and quarantine affected lots, discontinue use, and follow the manufacturer's recall instructions. Regulatory affairs professionals should verify distribution and implement corrective actions in accordance with the Canadian alert.
Tags: medical_device_recall, sterility, health_canada, infection_risk
Health Canada Recall: Cyanosure DermaV Laser System Performance Issue
2026-08-26 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the Cyanosure DermaV Laser System due to a performance issue. This affects Canadian healthcare facilities and practitioners that own or operate the device. Affected users should immediately consult the Health Canada notice, follow any manufacturer corrective actions, and report device-related adverse events to Health Canada.
Tags: medical_device_recall, laser_system, health_canada, performance_issue
Health Canada Recall: Med-Rx Medication/Primary Solution Administration Kit Performance Issue
2026-08-26 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a medical device recall alert for the Med-Rx Medication/Primary Solution Administration Kit due to performance issues. Healthcare institutions and providers using this kit should immediately check affected lot(s) and follow recall instructions. Patients may be impacted if the kit fails during medication or solution administration, so affected products should be quarantined and returned or replaced as directed.
Tags: medical_device_recall, performance_issue, health_canada, infusion_kit
Health Canada Recalls BIOFIRE® Joint Infection Panel – 30 Pack for Performance Issue
2026-08-26 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a recall/alert for the BIOFIRE® Joint Infection Panel – 30 Pack due to a performance issue. The alert affects laboratories and healthcare facilities using this multiplex PCR panel for joint infection testing. Users should identify affected lots, follow the manufacturer’s recall instructions, and monitor for potential inaccurate results or report incidents as appropriate.
Tags: health_canada, ivd_recall, performance_issue
Health Canada recalls GE CARESCAPE Central Station over performance issue
2026-08-26 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall/alert for the GE HealthCare CARESCAPE Central Station due to a performance issue that may affect device functionality. Healthcare facilities using this central monitoring station should review the recall notice, identify affected units, and contact GE HealthCare for corrective action. The issue may impact patient monitoring workflows, so risk assessments and interim mitigations should be implemented as needed.
Tags: medical_device_recall, health_canada, patient_monitoring, performance_issue
Health Canada Recalls Dräger VentStar Resus Neo and VentStar Resuscitaire for Performance Issue
2026-08-25 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a medical device recall alert for Dräger VentStar® Resus Neo and VentStar® Resuscitaire due to a performance issue. These neonatal resuscitation devices may not perform as intended during respiratory support. Healthcare facilities should identify affected products, quarantine them per the manufacturer's field safety notice, and contact Dräger for corrective action.
Tags: medical_device_recall, neonatal_resuscitation, performance_issue
ForeSight™ Oximeter Cable
2026-08-21 | Health Canada | Safety Communication | !! MEDIUM
Labelling and packaging
Health Canada Recall: Beckman Coulter iQ200 Series and DxU 840m/850m Iris Analyzers Performance Issue
2026-08-21 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for Beckman Coulter iQ200 Series Analyzers and DxU 840m/850m Iris Analyzers due to a performance issue. Laboratories and healthcare facilities using these urine analysis systems may be affected. Users should review the recall notice, follow the manufacturer's recommendations, and verify instrument performance before continuing clinical use.
Tags: medical_device_recall, performance_issue, health_canada, laboratory_diagnostics
Recall: GE HealthCare Aisys™ CS² and Carestation™ anesthesia systems due to performance issue
2026-08-21 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall alert for GE HealthCare Aisys™ CS² and Carestation™ anesthesia systems due to a performance issue. The alert affects healthcare facilities using these anesthesia machines. Affected users should identify impacted units, follow the manufacturer's corrective actions, and contact GE HealthCare for support.
Tags: medical_device_recall, anesthesia_systems, health_canada, performance_issue
Health Canada Safety Alert: IMRIS Table ORT 300 Performance Issue
2026-08-20 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the IMRIS Table ORT 300 due to a performance issue. The alert affects healthcare facilities using this table, potentially impacting device function or procedural safety. Regulatory affairs professionals should review the recall notice and ensure affected units are identified, assessed, and addressed according to the manufacturer's corrective action.
Tags: health_canada, medical_device_recall, performance_issue
Health Canada Recall/Alert: Patient Information Centre iX Performance Issue
2026-08-20 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a medical device recall/alert for the Patient Information Centre iX, citing a performance issue. Healthcare facilities using this patient monitoring/central station device should review the notice and follow the recommended corrective actions from Health Canada or the manufacturer. Affected users may need to contact the manufacturer for configuration changes or other corrective measures.
Tags: health_canada, medical_device_recall, patient_monitoring, performance_issue
Health Canada Recall/Alert: Theragun PRO Device Performance Issue
2026-08-20 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the Theragun PRO due to a performance issue. The notice affects users and distributors of the Theragun PRO in Canada. Affected parties should review the recall notice and follow the manufacturer's instructions, which may include stopping use or arranging for repair or replacement.
Tags: medical_device_recall, performance_issue, health_canada, theragun_pro
Health Canada Issues Recall for Centricity™ Enterprise Archive and PACS Workstation Over Performance Issue
2026-08-20 | Health Canada | Safety Communication | !!! HIGH
Health Canada has published a medical device recall/alert for the Centricity™ Enterprise Archive and PACS Workstation due to a performance issue. This affects healthcare facilities and users relying on these GE imaging archive and workstation products in Canada. Regulatory affairs and clinical engineering teams should review the alert, identify affected systems, and contact the manufacturer or Health Canada for remediation steps.
Tags: medical_device_recall, pacs, ge_healthcare
Health Canada Recalls StatStrip® Glucose and Beta-Ketone Hospital Meter Due to Performance Concern
2026-08-19 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the StatStrip® Glucose and Beta-Ketone Hospital Meter due to a performance issue. Healthcare facilities and professionals using this meter for glucose and beta-ketone testing are affected. Users should identify affected devices, follow the manufacturer's or Health Canada's recall instructions, and consider alternative testing methods where appropriate.
Tags: medical_device_recall, glucose_monitoring, performance_issue, health_canada
Health Canada Recall: Embosphere® Microspheres-Syringe – Sterility Issue
2026-08-19 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for Embosphere® Microspheres-Syringe due to a sterility concern. The affected product is used in embolization procedures and may pose an infection risk if sterility is compromised. Healthcare facilities should immediately quarantine affected lots, discontinue use, and follow the manufacturer’s recall instructions, while regulatory affairs professionals should verify inventory and report any adverse events.
Tags: canada_recall, sterility, embolization_microspheres
Health Canada Safety Alert: SPECTRALIS® with Flex Module Recall Due to Performance Issues
2026-08-19 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the SPECTRALIS® with Flex Module, citing performance-related concerns. Healthcare facilities and operators using this optical coherence tomography (OCT) ophthalmic imaging system should review the recall notice, identify affected units, and follow the manufacturer’s recommended corrective actions. This item is part of Canada’s latest medical device safety updates.
Tags: medical_device_recall, health_canada, ophthalmic_imaging, performance_issue
Health Canada Alert: Cook Medical Hemospray Kit Recalled Due to Performance Issue
2026-08-17 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the Cook Medical Hemospray Kit due to a performance issue. The device is used for endoscopic hemostasis, and affected Canadian healthcare facilities should identify and quarantine affected units. Users should consult the recall notice and contact Cook Medical for affected lot numbers and return or replacement instructions.
Tags: medical_device_recall, performance_issue, health_canada
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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