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Browse Device Recalls

2 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2 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 2 FDA device recalls.

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DateProductReasonClassFirm
Nov 27, 2024 OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01. Hydration issue resulting in the product being less cohesive and moldable than intended due to an... Class II IsoTis OrthoBiologics, Inc.
Nov 27, 2024 OsteoSurge 100 Demineralized Bone Matrix Putty with Accell Bone Matrix, Osteo... Incorrect expiration date listed on the outer box, which does not align with the correct expirati... Class II IsoTis OrthoBiologics, 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.