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Browse Device Recalls

3 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3 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 3 FDA device recalls.

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DateProductReasonClassFirm
Jan 9, 2026 Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720; Internal investigations have identified an issue with the durability of the connecting cable near... Class II Maquet Cardiopulmonary Gmbh
Jun 27, 2025 Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg... Device does not comply with the labeling requirements of international standard IEC 60601-1. Class II Maquet Cardiopulmonary Gmbh
Nov 13, 2019 Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane... Sterile barrier system may be compromised Class II GETINGE US SALES 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.