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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Mar 2, 2020 Siemens N Latex CDT Kit- IVD quantitative determination of carbohydrate-defic... Negative bias for the carbohydrate-deficient transferrin (CDT) measurement in comparison to the ... Class II CSL Behring GmbH
May 31, 2018 N Latex CDT Kit Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transf... Class II CSL Behring GmbH
Jun 5, 2017 SIEMENS N Protein Standard SL, for use on the BN II, BN ProSpec Systems, REF/... Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results ob... Class II CSL Behring GmbH
Jun 5, 2017 SIEMENS N/T Protein Control SL for use on the BN II, BN ProSpec Systems: N/T ... Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results ob... Class II CSL Behring GmbH
May 17, 2016 Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing N... Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the I... Class II CSL Behring GmbH

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.