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Browse Device Recalls

155 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 155 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 155 FDA device recalls.

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DateProductReasonClassFirm
May 16, 2012 ULTIMA*LX STM,POL 10/12TAP/SZ1 Packaging: The product was packaged within ... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 9 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 3 Packaging: The product was packaged within inner and outer b... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
May 16, 2012 LUSTER HIP SZ 1 Packaging: The product was packaged within inner and outer... DePuy Orthopaedics, Inc. is issuing a Field Safety Notice for the LUSTER Cemented Polished Femora... Class II DePuy Orthopaedics, Inc.
Mar 7, 2012 Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 ... DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner be... Class II DePuy Orthopaedics, 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.