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Browse Device Recalls

4 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4 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 4 FDA device recalls.

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DateProductReasonClassFirm
Apr 26, 2021 REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa

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.