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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Oct 11, 2021 Bartels Legionella Urinary Antigen- an adjunct to culture for the presumptive... Contamination of the conjugate may cause a pipetting issue which then could lead to an invalid assay Class II Clark Laboratories, Inc.
Mar 17, 2021 Trinity Biotech Captia Measles IgM Kit, Catalog No. 2326060 - Product Usage: ... Positive Control may run high out of its assigned ISR range and result in an invalid run and nece... Class II Clark Laboratories, Inc.
Nov 1, 2018 Genesys Diluent Reagent, REF 01-03-0019 intended to be used with automated hi... lack of 510K Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018 Genesys 1 Reagent, REF 01-03-0020 intended to be used with automated high per... lack of 510K Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018 Genesys Analytical Column, REF 01-05-0017 intended to be used with automated ... lack of 510K Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018 Genesys 2 Reagent, REF 01-03-0022 intended to be used with automated high per... lack of 510K Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 1, 2018 ultra2 Genesys Variants Analyzer, REF 03-01-0045 intended to be used with aut... lack of 510K Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Jul 11, 2016 Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 ... The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator ... Class III Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Nov 17, 2014 Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 80... Through in-house routine real time stability monitoring of Trinity's Captia Syphilis IgM Capture ... Class III Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Aug 27, 2013 Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay f... Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results. Class II Clark Laboratories, Inc. (dba,Trinity Biotech USA)
May 29, 2012 Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code... The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as run... Class III Clark Laboratories, Inc. (dba,Trinity Biotech USA)

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.