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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
May 20, 2016 Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. Product did not meet specifications for Zinc Acetate (OOS). Class II Amerx Health Care Corp.
Feb 25, 2015 Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. Nonapproved labeling claims (Sterile) Class II Amerx Health Care Corp.
Sep 26, 2014 Amerigel Daily Dressing Packets Wound management Formulation deviation Class II Amerx Health Care Corp.
Sep 26, 2014 Amerigel Hydrogel Wound Dressing Wound management Formulation deviation Class II Amerx Health Care Corp.
Sep 26, 2014 Amerigel Post-op Surgical Kits Wound management Formulation deviation Class II Amerx Health Care Corp.
Sep 26, 2014 Amerigel Saturated Gauze Dressing Wound management Formulation deviation Class II Amerx Health Care Corp.
Jul 11, 2014 Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amer... Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jul 11, 2014 Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management. Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jul 11, 2014 Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets... Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.
Jul 11, 2014 Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads siz... Not approved labeling claims (antimicrobial and autolytic debridement) Class II Amerx Health Care Corp.

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.