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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Jun 17, 2025 QuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, ... Dipstick strep A test has potential for false positive results. Class II Quidel Corporation
Mar 5, 2024 QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests There are two windows on the test device, the control line window and the test results window. Th... Class II Quidel Corporation
Mar 5, 2024 QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests There are two windows on the test device, the control line window and the test results window. Th... Class II Quidel Corporation
Jan 3, 2024 The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a... One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration... Class II Quidel Corporation
Feb 1, 2023 MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhi... Kits with affected microtiter plates have the potential to produce low OD values, causing the run... Class II Quidel Corporation
Aug 13, 2021 Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The ... Revised Instructions for Use: Potential for specimens from patients with high SARS-CoV-2 viral lo... Class II Quidel Corporation
Apr 27, 2021 Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent In rare situations patients infected with high viral load of SARS CoV 2 may have samples that gen... Class I Quidel Corporation
Sep 25, 2020 QUIDEL Sofia SARS Antigen FIA IVD REF 20374 Due to false positive results. Class II Quidel Corporation
Sep 17, 2020 Sofia SARS Antigen FIA Package Insert The Sofia SARS Antigen FIA is a lat... Instructions for use in the package insert for SARS Antigen FIA test were updated to remove all r... Class II Quidel Corporation
Dec 15, 2017 Sofia 2 Analyzer Catalog Number 20299 Sofia 2 is a bench top analyzer in... The calibration for the affected batch of analyzers was incorrectly set during the manufacturing ... Class II Quidel Corporation
Jun 22, 2017 InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) ... In-house testing revealed the presence of plastic spurs at the tips of some Sample Collectors. Class II Quidel Corporation
Jan 25, 2017 Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packa... Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incor... Class II Quidel Corporation
Dec 3, 2012 Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnos... Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B F... Class II Quidel Corporation

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.