Browse Device Recalls

53 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 53 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 53 FDA device recalls.

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DateProductReasonClassFirm
May 22, 2012 Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative det... Certain lots of the affected products may have significantly decreased precision relative to the ... Class I Alere San Diego, Inc.
May 14, 2012 Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triag... A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may ... Class II Alere San Diego, Inc.
May 28, 2009 Triage TOX Drug Screen Panel, Model# 94400. Product Usage: The Triage T... Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices becaus... Class II Alere San Diego, 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.