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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
Feb 5, 2021 Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination ... Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labelin... Class III OraSure Technologies, Inc.
Jul 15, 2020 CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: ind... Unit boxes not properly sealed Class III OraSure Technologies, Inc.
Jul 15, 2020 Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product... Unit boxes not properly sealed Class III OraSure Technologies, Inc.
Jul 15, 2020 Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 100... Unit boxes not properly sealed Class III OraSure Technologies, Inc.
Jul 13, 2020 Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate ... Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included ... Class III OraSure Technologies, Inc.
Jul 13, 2020 Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate... Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included ... Class III OraSure Technologies, Inc.
Dec 20, 2017 Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (01006083370... The controls and calibrators contained within the cocaine test kit may cause false positive resul... Class III OraSure Technologies, Inc.
Nov 10, 2016 Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) P... Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due t... Class III OraSure Technologies, Inc.
Jul 20, 2016 OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for th... Failed stability testing at 8 months. This lot produced intermittent false negative results for ... Class I OraSure Technologies, Inc.
Jan 15, 2016 OraQuick HCV Visual Reference Panel Intended to assist new operation in b... OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Ant... Class III OraSure Technologies, 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.