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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Apr 19, 2017 Oxford/Oxbridge AFN End Cap 10 mm x 5 mm tp 12 mm x10 mm The end caps ar... There is a material mislabeling of the AFN End Cap. Class II Ortho Solutions Inc
Jul 21, 2016 FPS 35mm x 3.5 mm non-locking screw Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws. Class II Ortho Solutions Inc
Jul 14, 2015 Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD... Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking th... Class II Ortho Solutions Inc

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.