Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

81 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 81 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 81 FDA device recalls.

Clear
DateProductReasonClassFirm
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.
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.
Jun 12, 2017 VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Or... The firm identified the potential for biased results to be generated when processing VITROS PHYT ... Class II Ortho-Clinical Diagnostics
Jan 5, 2017 VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, I... The company received a customer complaint for the inability to calibrate VITROS Chemistry Product... Class III Ortho-Clinical Diagnostics
Jul 15, 2014 VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and... Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Cali... Class II Ortho-Clinical Diagnostics
Mar 26, 2014 VITROS Chemistry Products FS Diluent Pack 3, REF 680 1754, 3 x 45 mL, (D1)/15... Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Prote... Class II Ortho-Clinical Diagnostics
Mar 26, 2014 VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- ... Ortho Clinical Diagnostics (OCD) confirmed the potential for lower than expected C-Reactive Prote... Class II Ortho-Clinical Diagnostics
Mar 5, 2014 VITROS Chemistry Products CRBM Slides, REF 889 2382, IVD -- Ortho-Clinical Di... The firm identified a potential for biased carbamazepine (CRBM) results to be generated when usin... Class II Ortho-Clinical Diagnostics
Jan 29, 2014 VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalo... Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Prod... Class II Ortho-Clinical Diagnostics
Feb 7, 2013 VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemis... Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems ... Class II Ortho-Clinical Diagnostics
Feb 7, 2013 VITROS 5600 Integrated System, Product Code 6802413. Intended for use in t... Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some VITROS¿ Systems ... Class II Ortho-Clinical Diagnostics
Feb 7, 2013 VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Product Co... Ortho-Clinical Diagnostics, Inc. (OCD) determined that extension springs on some 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.