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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.

Clear
DateProductReasonClassFirm
Feb 7, 2024 Torrent Suite Dx Software versions 5.14 and earlier used in connection with I... Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems ex... Class II Life Technologies Corporation
Aug 6, 2020 The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv... COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes... Class II Life Technologies Corporation
Aug 6, 2020 The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem's COVID-19 Interpretiv... COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tes... Class II Life Technologies Corporation
Mar 16, 2020 Oncomine Dx Target Test RNA Control- IVD for detection of DNA and RNA isolate... Extended Expiration Date prior to clearance Class II Life Technologies Corporation
Mar 16, 2020 Ion Torrent Dx No Template Control Kit- IVD for detection of DNA and RNA isol... Extended Expiration Date prior to clearance Class II Life Technologies Corporation
Mar 16, 2020 Oncomine Dx Target Test RNA/DNA Panel- IVD for detection of DNA and RNA isola... Extended Expiration Date prior to clearance Class II Life Technologies Corporation
Mar 16, 2020 Oncomine Dx Target Test DNA Control-IVD for detection of DNA and RNA isolated... Extended Expiration Date prior to clearance Class II Life Technologies Corporation
Jun 11, 2019 CTSTM Essential 8 Medium Component was not tested by the supplier for adventitious agents Class II Life Technologies Corporation
Jun 11, 2019 StemPro¿ MSC SFM CTS" Component was not tested by the supplier for adventitious agents Class II Life Technologies Corporation
Feb 8, 2018 Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel... The lower concentration of the RNA panel could cause a NO CALL or FALSE NEGATIVE for the reportin... Class II Life Technologies Corporation
Feb 7, 2018 Human Fetal Hemoglobin (HBF-1) FITC Conjugate Three lots of Human Fetal Hemoglobin FITC Conjugate are displaying high background and unusual br... Class II Life Technologies Corporation
Dec 4, 2017 Oncomine Dx Target Test User Guides and Assay Definition File, Model: A32461;... The Oncomine Dx Target Test may report erroneous results when used off-label for samples other th... Class II Life Technologies Corporation
May 13, 2013 HSV 2 Primers, Catalog #18081020. Analyte Specific Reagent. The HSV-2 primer ... Firm received complaints that HSV-2 primers failed to amplify HSV-2 DNA. Class II Life Technologies 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.