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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 6 FDA device recalls.

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DateProductReasonClassFirm
Apr 5, 2022 The following first aid kits and cabinets containing components Medi-First XS... First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at... Class II Certified Safety Mfg Inc
Apr 25, 2018 Nanosil Spray Gel, "***IMMUNE SYSTEM SUPPORT***ENGINEERED NANO-SILVER SOLUTIO... A recent FDA inspection of the firm revealed significant Current Good Manufacturing Practices (cG... Class II Conseal International, Inc.
Mar 21, 2014 Amerigel Wound Dressing 55 gallons/drum Product may not have been manufactured pursuant to a validated process protocol and CGMP. Class II Kova Laboratories, Inc.
Mar 21, 2014 Amerigel Wound Dressing 1 oz. tube Product may not have been manufactured pursuant to a validated process protocol and CGMP. Class II Kova Laboratories, Inc.
May 20, 2010 HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, ... CGMP Deviations: Incomplete documentation associated with test results. Class II App Pharmaceuticals Llc
May 20, 2010 HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, ... CGMP Deviations: Incomplete documentation associated with test results. Class II App Pharmaceuticals Llc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.