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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 12, 2014 Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350... A small number of sealed foil pouches containing the electrodes were found to be difficult to ope... Class II Heartsine Technologies, Limited
Sep 13, 2012 HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to... Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions tha... Class I Heartsine Technologies, Limited

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.