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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.

Clear
DateProductReasonClassFirm
Jan 13, 2022 COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibod... COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... Class I Lusys Laboratories, Inc.
Jan 13, 2022 LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Ca... COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... Class I Lusys Laboratories, Inc.
Jan 13, 2022 Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mu... COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, clear... Class I Lusys Laboratories, Inc.
Mar 13, 2015 Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus ... LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... Class I Lusys Laboratories, Inc.
Mar 13, 2015 Ebola Accessories assembled, self-contained package, Catalog No. I-104 vir... LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... Class I Lusys Laboratories, Inc.
Mar 13, 2015 Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials P... LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... Class I Lusys Laboratories, Inc.
Mar 13, 2015 Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. ... LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... Class I Lusys Laboratories, Inc.
Mar 13, 2015 Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Mater... LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... Class I Lusys Laboratories, Inc.
Mar 13, 2015 Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... Class I Lusys Laboratories, Inc.
Mar 13, 2015 Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. T... LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... Class I Lusys Laboratories, Inc.
Mar 13, 2015 Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials P... LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of... Class I Lusys Laboratories, 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.