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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Feb 10, 2025 Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal... Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative... Class II Immuno-Mycologics, Inc
Jan 3, 2022 CRYPTOCOCCAL ANTIGEN LATERAL FLOW ASSAY, IMMY, Lateral Flow Assay for the Det... The firm found immunoassay products used to detect cryptococcal antigen in serum and cerebrospina... Class II Immuno-Mycologics, Inc
Nov 4, 2019 Histoplasma Immunodiffusion (ID) Antigen; The IFU labeling is for multiple pr... False positive results due to potential contamination of reagent. Class II Immuno-Mycologics, Inc
Mar 30, 2018 Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product... Potential for LFA strips to improperly wick which may cause false negative cryptococcosis test re... Class II Immuno-Mycologics, Inc
Dec 27, 2016 Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003 The affected products have approximately a 91% specificity while the non-affected lots have appro... Class II Immuno-Mycologics, Inc
May 9, 2016 Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal ... The device was found to have bacterial contamination. Class II Immuno-Mycologics, 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.