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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
Jun 4, 2019 Powerheart¿ G5 Automatic AED Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determi... Class II Cardiac Science Corporation
Jan 14, 2016 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 ... Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too h... Class II Cardiac Science Corporation

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.