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
Aug 10, 2016 Neural Signal Amplifier. Part Numbers: 4208, 5703, 5749, 5748, 5747. Produ... Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopot... Class II Blackrock Microsystems, LLC
Aug 10, 2016 Patient Cable. Part Numbers: 4460, 6735. Sterile within Chipboard Boxes withi... Blackrock Microsystems, LLC announces a voluntary field action for the Blackrock NeuroPort Biopot... Class II Blackrock Microsystems, LLC

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.