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Browse Device Recalls

454 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 454 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 454 FDA device recalls.

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DateProductReasonClassFirm
May 29, 2012 syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. ... When using the syngo Quality Control package the system may not perform as intended for Multi-Rul... Class II Siemens Healthcare Diagnostics, Inc.
May 29, 2012 EasyLink Informatic System is included with the Dimension Vista System. The ... When using the EasyLink Quality Control Package the system may not perform as intended for Multi-... Class II Siemens Healthcare Diagnostics, Inc.
May 8, 2012 Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B1... Siemens Healthcare Diagnostics has confirmed that the presence of Intrinsic Factor Blocking Antib... Class II Siemens Healthcare Diagnostics, Inc.
Dec 1, 2010 BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usag... Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithr... Class II Siemens Healthcare Diagnostics, Inc.

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.