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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
Nov 28, 2019 aap Implantate AG, Soft tissue retractor, radiolucent, REF IU 7971-00 The company has become aware that the soft tissue retractor is not always removed during the sawi... Class II AAP Implantate Ag
Jan 25, 2019 INTEGRA, Drill CS 4.0, quick coupling single use, REF 430425 Products were distributed with the incorrect instructions for use. Class III AAP Implantate Ag
Jan 25, 2019 INTEGRA, Drill CS 4.5, quick coupling single use, REF 430453 Products were distributed with the incorrect instructions for use. Class III AAP Implantate Ag
Jan 11, 2019 aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Su... There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel b... Class II AAP Implantate Ag

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.