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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
Jan 30, 2026 DxC 700 AU, REF: B86444, B86446 A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... Class II Beckman Coulter Mishima K.K.
Jan 30, 2026 CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC instal... Class II Beckman Coulter Mishima K.K.
Apr 30, 2025 Sample probe sucks a sample dispensed into a tube or cup and discharges the ... Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to... Class II Beckman Coulter Mishima K.K.
Apr 30, 2025 Sample probe sucks a sample dispensed into a tube or cup and discharges the ... A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S p... Class II Beckman Coulter Mishima K.K.
Jul 10, 2024 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent r... Class II Beckman Coulter Mishima K.K.
Jun 5, 2024 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved f... Class II Beckman Coulter Mishima K.K.

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.