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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.