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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Sep 18, 2025 HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-P... Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanic... Class II HeartSine Technologies Ltd
Jun 30, 2025 HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The Hea... Due to a component manufacturing issue, Automated External Defibrillator may not function properl... Class II HeartSine Technologies Ltd
Apr 8, 2024 HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 36... Automated external defibrillators have a manufacturing issue that could prevent the device from d... Class II HeartSine Technologies Ltd
Feb 14, 2024 HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P... Automated external defibrillators were shipped in their test configuration so there is a potentia... Class II HeartSine Technologies Ltd
Apr 26, 2023 HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separate... Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cel... Class II HeartSine Technologies Ltd
Feb 1, 2023 Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P ful... Automated external defibrillators were potentially distributed with the incorrect language config... Class II HeartSine Technologies Ltd

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.