FDA Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
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
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
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
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
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