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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Sep 25, 2024 intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buff... Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohi... Class II Biocare Medical, LLC
Feb 25, 2021 BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Mod... Their is a potential that the automated staining instrument with software version 3.5.3.1 may mo... Class II Biocare Medical, LLC
Oct 10, 2019 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase... Firm has identified product has no staining. If used, may result in invalid test results when use... Class II Biocare Medical, LLC
Apr 24, 2018 Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) proced... Chromogen failed to develop due to a stability issue caused by environmental factors with a raw m... Class II Biocare Medical, LLC
Mar 15, 2018 URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type... Immunohistochemistry device kits found to display incorrect staining pattern due to mislabeling o... Class II Biocare Medical, LLC
Mar 31, 2016 Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog... Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some ... Class III Biocare Medical, LLC
Sep 8, 2015 Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CM... Certain catalog numbers and lots of Smooth Muscle Actin may stain some cell types that are typica... Class II Biocare Medical, LLC
May 6, 2015 D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA ... Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. Class III Biocare Medical, LLC
Mar 17, 2015 CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage... A drop in staining intensity over time has been observed. These lots may not meet their labeled s... Class II Biocare Medical, LLC

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.