Browse Device Recalls
24 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 24 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 24 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Jun 30, 2015 | VITROS 5,1 FS Chemistry System, Catalog Number/Product Code 6801375, Unique D... | Software anomaly may occur during the installation of an Assay Data Diskette (ADD) using Software... | 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.