Browse Device Recalls

126 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 126 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 126 FDA device recalls.

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DateProductReasonClassFirm
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAG... transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC VANCOMYCIN (300/BX)ORCLNL REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC VITROS CALCIUM (L-SEQUESTER) (300/PK) REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 24, 2025 ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML. transit delays of certain cold chain products due to severe thunderstorms which may caused the pr... Class II Mckesson Medical-Surgical Inc. Corporate Office
Oct 25, 2023 VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITR... Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coa... Class II Ortho-Clinical Diagnostics, INc.
Aug 9, 2023 Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry Sy... Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactur... Class II Ortho-Clinical Diagnostics, Inc.
Oct 15, 2021 VITROS Immunodiagnostic Products Anti-HBc IgM Controls, Product Code 6801427 ... Ortho Clinical Diagnostics confirmed a complaint that some VITROS Immunodiagnostic Products Anti-... Class III Ortho-Clinical Diagnostics, Inc.
Sep 10, 2021 VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (I... VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Co... Class II Ortho Clinical Diagnostics Inc
Dec 15, 2020 VITROS Chemistry Products TP Slides- IVD measure total protein (TP) concentra... Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Product... Class II Ortho Clinical Diagnostics Inc
Dec 15, 2020 VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quanti... Eltrombopag Interference for VITROS Chemistry Products TP Slides and VITROS XT Chemistry Product... Class II Ortho Clinical Diagnostics Inc
Dec 11, 2020 VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide car... VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interfe... Class II Ortho Clinical Diagnostics Inc
Oct 16, 2020 VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use... Product instability; biased ALKP values obtained from VITROS Chemistry Products Performance Verif... Class III Ortho Clinical Diagnostics Inc
Sep 30, 2020 VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: I... Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiag... Class II Ortho Clinical Diagnostics Inc
Sep 30, 2020 VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage... Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiag... Class II Ortho Clinical Diagnostics Inc
Jul 20, 2020 VITROS XT3400 Chemistry System, Product code 6844458 When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. A... Class II Ortho Clinical Diagnostics
Jul 20, 2020 VITROS XT7600 Integrated System, Product code 6844461 When processing MicroSlides, slides that utilize Slot 18 in the CM rotor may be mis-positioned. A... Class II Ortho Clinical Diagnostics
Jul 17, 2020 VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6... The reagent bottles may be swapped within the reagent pack, which may lead to false negative resu... Class II Ortho Clinical Diagnostics
Jul 17, 2020 VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog numbe... The reagent bottles may be swapped within the reagent pack, which may lead to false negative resu... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Un... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS 5600 Integrated System Software Versions 3.3.3 and below Product C... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Produ... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
May 20, 2020 VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Produc... Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset ... Class II Ortho Clinical Diagnostics
Mar 10, 2020 VITROS Immunodiagnostic Products TT4 Reagent Pack, Product Code 8744468 The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations. Class III Ortho Clinical Diagnostics
Dec 16, 2019 VITROS Chemistry Products Calibrator Kit 2- IVD calibrator for VITROS 250/35... Potential for Negatively Biased Na+ Urine Results Using Several Lots of VITROS Chemistry Product... Class II Ortho Clinical Diagnostics Inc
Oct 14, 2019 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used... Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Uri... Class II Ortho Clinical Diagnostics Inc
Oct 14, 2019 Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dil... Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Uri... Class II Ortho Clinical Diagnostics Inc
Jul 8, 2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 5600 Integrated System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 350 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 4600 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 4600 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 250AT Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical che... Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 5,1 FS Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 250 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 250 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Jul 8, 2019 VITROS 5600 Integrated System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class II Ortho Clinical Diagnostics
Nov 29, 2018 Vitros Myoglobin Calibrators, Product Code 6801043 For use in the calibration... A stability issue in the calibrators may cause calibration failures or atypical Quality Control r... Class II Ortho Clinical Diagnostics Inc
Jul 12, 2018 VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997 The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... Class II Ortho Clinical Diagnostics Inc
Jul 12, 2018 VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1... The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... Class II Ortho Clinical Diagnostics Inc
Jul 12, 2018 VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922 The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... Class II Ortho Clinical Diagnostics Inc
Jul 12, 2018 VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266 The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic ... Class II Ortho Clinical Diagnostics Inc
Jul 10, 2017 VITROS Chemistry Products Performance Verifier is used as an assayed control ... VITROS Performance Verifier II (PVII) Lot K4852 does not meet long term stability requirements fo... Class III Ortho Clinical Diagnostics Inc
Feb 21, 2017 VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Ide... Potential for biased results generated using the specific lots of VITROS VANC Reagent. This can ... Class II Ortho-Clinical Diagnostics
Feb 1, 2017 VITROS Chemistry Products Li (Lithium) Slides, REF/Catalog Number/Product Cod... Intermittent imprecision in results generated using two specific lots of VITROS Li Slides. Class II Ortho-Clinical Diagnostics

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.