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Browse Device Recalls

10 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 10 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 10 FDA device recalls.

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DateProductReasonClassFirm
Aug 11, 2025 Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... Their is the potential for weak staining which may result in false negative CD20 identification. Class II Agilent Technologies Denmark ApS
Aug 11, 2025 Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... Their is the potential for weak staining which may result in false negative CD20 identification. Class II Agilent Technologies Denmark ApS
Aug 11, 2025 Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use ... Their is the potential for weak staining which may result in false negative CD20 identification. Class II Agilent Technologies Denmark ApS
Mar 20, 2025 GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA fe... DNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a... Class II Agilent Technologies, Inc.
Apr 2, 2024 Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: CoverStai... There is the potential for the front plexiglass door of the automated slide processing system to ... Class II Agilent Technologies
Feb 17, 2023 Agilent Resolution ctDx FIRST Sample Collection Kit, 500032 Distributed sample collection kit with an unapproved instruction for use. Class III AGILENT TECHNOLOGIES INC./US
May 20, 2022 Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2... Label provided for substrate vail contained incorrect expiration date. Class III Agilent Technologies, Inc.
Aug 15, 2018 MassHunter Quantitative Analysis Software, Version B.07.01, used with Triple ... When utilizing specific software versions of an LC/MS device, and Batch at a Glance in Compound T... Class II Agilent Technologies, Inc.
Jun 17, 2015 Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 50... The product was marketed without 510(k) clearance. Class II Agilent Technologies, Inc.
Feb 1, 2012 i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test i... The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmo... Class II Abbott Point Of Care 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.