Browse Device Recalls

273 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 273 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 273 FDA device recalls.

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DateProductReasonClassFirm
Jun 5, 2023 VITROS Immunodiagnostic Products Troponin I ES Calibrators Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... Class II ORTHO-CLINICAL DIAGNOSTICS
Jun 5, 2023 VITROS Immunodiagnostic Products Troponin I ES Reagent Pack Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... Class II ORTHO-CLINICAL DIAGNOSTICS
May 18, 2023 VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro di... May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU). Class III Ortho-Clinical Diagnostics, Inc.
May 8, 2023 VITROS Chemistry Products Calibrator Kit 20-in vitro diagnostic use only. VI... Potential to cause biased results in the upper end of the reportable range for the quantitative m... Class II Ortho-Clinical Diagnostics
Apr 17, 2023 VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determi... Potential for both unexpected positive and negative HbA1c results, may result in misdiagnosis Class II Ortho-Clinical Diagnostics, Inc.
Apr 14, 2023 VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 ... Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in ... Class II Ortho-Clinical Diagnostics, Inc.
Mar 10, 2023 VITROS 5600 Integrated System - Refurbished . For use in the in vitro quanti... MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿... Class II Ortho-Clinical Diagnostics, Inc.
Mar 10, 2023 VITROS XT 7600 Integrated System - For use in the in vitro quantitative, semi... MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿... Class II Ortho-Clinical Diagnostics, Inc.
Mar 10, 2023 VITROS 5600 Integrated System- For use in the in vitro quantitative, semi-qua... MicroTip Pack Opener Assembly Potentially Not Removing or Replacing MicroTip Pack Caps on VITROS¿... Class II Ortho-Clinical Diagnostics, Inc.
Mar 9, 2023 VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrator... Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS... Class II Ortho-Clinical Diagnostics, Inc.
Nov 17, 2022 VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quanti... Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPT... Class II Ortho-Clinical Diagnostics, Inc.
Oct 13, 2022 VITROS Chemistry Products Calibrator Kit 9 -(GEN) 22 of VITROS PHYT Slides F... Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathem... Class II Ortho-Clinical Diagnostics, Inc.
Jul 19, 2022 VITROS XT 3400 Chemistry System with Version 3.7.2 and below Product Code: 6... Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... Class II Ortho-Clinical Diagnostics, Inc.
Jul 19, 2022 VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: ... Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or... Class II Ortho-Clinical Diagnostics, Inc.
May 26, 2022 Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS¿ E... On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in th... Class II Ortho-Clinical Diagnostics, Inc.
Mar 25, 2022 VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 184... Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun... Class II Ortho-Clinical Diagnostics, Inc
Mar 25, 2022 VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun... Class II Ortho-Clinical Diagnostics, Inc
Mar 25, 2022 VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198 Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immun... Class II Ortho-Clinical Diagnostics, Inc
Dec 10, 2021 VITROS Chemistry Products VersaTips, Catalog No. 6801715 A VersaTip sales ... The lot has a shape deformity which may lead to a 16% reduction in the volume of the sample or re... Class II Ortho-Clinical Diagnostics, Inc.
Nov 22, 2021 VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Lower than expected results for VITROS¿ Immunodiagnostic Products TSH Reagent Pack when diluted w... 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.
May 3, 2021 VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemi... Ortho investigated and confirmed the potential for unexpected failed calibration, and condition c... Class II Ortho-Clinical Diagnostics, INc.
Mar 26, 2021 VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black R... Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly l... Class II Ortho-Clinical Diagnostics, INc.
Feb 18, 2021 VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only).... Potential total iron-binding capacity (TIBC) results. The VITROS TIBC performance shift will sta... Class II Ortho-Clinical Diagnostics, Inc.
Feb 12, 2021 VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnos... VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using ... Class II Ortho-Clinical Diagnostics, Inc.
Feb 12, 2021 VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products... VITROS Immunodiagnostic Products SARS-CoV-2 Antigen False Reactive Results Associated When Using ... Class II Ortho-Clinical Diagnostics, Inc.
Jan 14, 2021 VITROS Chemistry Products VersaTips - Product Usage: used to dispense samples... A deformity affecting a specific lot of VITROS¿ Chemistry Products VersaTips. Deformed VersaTips ... Class II Ortho-Clinical Diagnostics, Inc.
Nov 20, 2020 VITROS Automation Solutions, VAS, Catalog Numbers 6844300 & 6844301 - Product... A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... Class II Ortho-Clinical Diagnostics, Inc.
Nov 20, 2020 enGen Laboratory Automation System, enGen Track System, Catalog Number ENGEN ... A software anomaly may cause an aliquoted sample to be labelled as the incorrect sample. This may... Class II Ortho-Clinical Diagnostics, Inc.
Jul 13, 2020 VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS ... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS... Class II Ortho-Clinical Diagnostics
Jul 13, 2020 VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic q... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS... Class II Ortho-Clinical Diagnostics
Jul 13, 2020 VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro... Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS... Class II Ortho-Clinical Diagnostics
May 11, 2020 VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/90 SLDS, Product... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 11, 2020 VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI #... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 11, 2020 VITROS Chemistry Product AMYL Slides Reagent, AMYLASE/5 PACK/300 SLDS, Produc... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
May 11, 2020 VITROS Chemistry Product Performance Verifier I, Product Code 8231474, UDI # ... Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fl... Class II Ortho-Clinical Diagnostics
Apr 1, 2020 VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 805 8... The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plas... Class II Ortho-Clinical Diagnostics
Apr 1, 2020 VITROS Chemistry Products CKMB Slides, Creatine Kinase MB, Product Code 80011... The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plas... Class II Ortho-Clinical Diagnostics
Sep 10, 2019 VITROS chemistry Products Cl- Slides, Catalog No. 6844471 (which supports Uri... Users may experience intermittent slide dispense issues with some cartridges due to the anti-back... Class II Ortho-Clinical Diagnostics
Sep 10, 2019 VITROS chemistry Products K+ Slides, Catalog No. 8157596. MicroSlides which c... Users may experience intermittent slide dispense issues with some cartridges due to the anti-back... Class II Ortho-Clinical Diagnostics
Sep 10, 2019 VITROS chemistry Products Cl- Slides, Catalog No. 8445207 (which does NOT sup... Users may experience intermittent slide dispense issues with some cartridges due to the anti-back... Class II Ortho-Clinical Diagnostics
Jun 17, 2019 VITROS Chemistry Products GLU Slides-Product Code:1707801. IVD VITROS Chem... Potentially Biased Results using VITROS Chemistry Products GLU Slides Class II Ortho-Clinical Diagnostics
Apr 8, 2019 VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) ... Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... Class II Ortho-Clinical Diagnostics
Apr 8, 2019 VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 107587... Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... Class II Ortho-Clinical Diagnostics
Apr 8, 2019 VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) ... Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... Class II Ortho-Clinical Diagnostics
Apr 8, 2019 VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) ... Potential negative drift in Creatine Kinase (CK) results when used on the VITROS 250 and 350 Syst... Class II Ortho-Clinical Diagnostics
Mar 20, 2019 VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 684446... Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentiall... Class II Ortho-Clinical Diagnostics
Mar 11, 2019 VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 ... One of the software algorithms used to detect sample dispense errors was inadvertently disabled. ... Class II Ortho-Clinical Diagnostics
Feb 20, 2019 VITROS¿ 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product ... Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems Class II Ortho-Clinical Diagnostics
Feb 20, 2019 VITROS¿ XT 7600 Integrated System-Software V3.4.1 & below Product Code: 684... Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems 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.