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 |
|---|---|---|---|---|
| Feb 20, 2019 | VITROS ECi Immunodiagnostic System Refurbished Product Code: 6801059 For... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ 5600 Integrated 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¿ 5600 Integrated System -Software V3.3.2 & below Product Code: 6802... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ ECi/ECiQ Immunodiagnostic System Product Code: 1922814 For use ... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Feb 20, 2019 | VITROS¿ 3600 Immunoassay System-Software V3.3.2 & below Product Code: 680278... | Luminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS¿ Systems | Class II | Ortho-Clinical Diagnostics |
| Jan 22, 2019 | VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro ... | Imprecision in the affected lot may produce negatively or positively biased patient sample and qu... | Class II | Ortho-Clinical Diagnostics |
| Dec 11, 2018 | VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only... | Negative bias results when using VITROS VALP Reagent, GEN 25. | Class II | Ortho-Clinical Diagnostics |
| Nov 1, 2018 | VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qua... | The firm is extending their previous July 2018 recall to include additional product codes. Biased... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Nov 1, 2018 | VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in v... | The firm is extending their previous July 2018 recall to include additional product codes. Biased... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Nov 1, 2018 | VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro dia... | The firm is extending their previous July 2018 recall to include additional product codes. Biased... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Oct 19, 2018 | VITROS 5600 Integrated System, Version 3.3.1 & below For use in the in vi... | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | Class II | Ortho-Clinical Diagnostics |
| Oct 19, 2018 | VITROS 4600 Chemistry System, Version 3.3.1 & below For use in the in vit... | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | Class II | Ortho-Clinical Diagnostics |
| Oct 19, 2018 | VITROS¿ 3600 Immunodiagnostic System, Version 3.3.1 & below For use in th... | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | Class II | Ortho-Clinical Diagnostics |
| Oct 19, 2018 | VITROS 5,1 FS Chemistry System, Version 3.0 & below For use in the in vit... | Software anomaly may incorrectly extend the on-analyzer stability time for a loaded VITROS Reagent. | Class II | Ortho-Clinical Diagnostics |
| Oct 8, 2018 | VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to ... | VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results | Class II | Ortho-Clinical Diagnostics |
| Aug 28, 2018 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number... | The reagent pack exhibits the potential for an increased frequency of calibration failures. | Class II | Ortho-Clinical Diagnostics |
| Aug 15, 2018 | VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quan... | Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a ... | Class II | Ortho-Clinical Diagnostics |
| Aug 15, 2018 | VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quanti... | Potential for the VITROS 5600 Integrated System to dispense an insufficient sample volume onto a ... | Class II | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage:... | The slides failed to meet current claims for Limit of Blank (LoB), Limit of Detection (LoD) and L... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 684 4471 Product Usage ... | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products CREA Slides, Product Code 680 2584 Product Usag... | The slides did not meet the current claims for Limit of Blank (LoB), Limit of Detection (LoD) and... | Class III | Ortho-Clinical Diagnostics |
| Jul 11, 2018 | VITROS Chemistry Products Cl- Slides, Product Code 844 5207 Product Usage:... | The slides do not meet the maximum allowable interference (MAI) claims for triglyceride interfere... | Class III | Ortho-Clinical Diagnostics |
| May 9, 2018 | VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diag... | There is a potential for imprecise results when using the slides. Increase in imprecision when u... | Class II | Ortho-Clinical Diagnostics |
| May 5, 2018 | VITROS Sodium Slides, Catalog # 837 9034 | Potential for positively biased results | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier I in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier III in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier II in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| Sep 22, 2017 | VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Veri... | Class II | Ortho-Clinical Diagnostics |
| 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 |
| Apr 26, 2017 | enGen Track System with TCAutomation Software Version 4.2 | A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results d... | Class II | Ortho-Clinical Diagnostics |
| Mar 8, 2017 | enGen (TM) Laboratory Automation Systems using all TCAutomation(TM) Software ... | Software anomaly; Thermo-Fisher Scientific initially discovered and Ortho-Clinical Diagnostics, s... | Class II | Ortho-Clinical Diagnostics |
| Mar 7, 2017 | VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 215... | Increased frequency of calibration failures for VITROS Immunodiagnostic Products NT-proBNP Reagen... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| 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 |
| 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 |
| Dec 20, 2016 | VITROS Na+ Slides, (UPN 10758750004812) For in vitro diagnostic use only. ... | There is a potential for biased results to be generated over the 10 day on-analyzer storage limit... | Class II | Ortho-Clinical Diagnostics |
| Dec 8, 2016 | VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usag... | There is a potential for variable negatively and positively biased urine protein results using VI... | Class II | Ortho-Clinical Diagnostics |
| Oct 26, 2016 | VITROS CRP Slides: 1) VITROS¿ Chemistry Products CRP Slides (250 slides per ... | CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products ... | Class III | Ortho-Clinical Diagnostics |
| Oct 5, 2016 | VITROS Immunodiagnostic Products Intact PTH Reagent Pack: 1) UPN 107587500062... | The device defect is a positive bias of up to 20% relative to the currently marketed Roche device... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Sep 7, 2016 | enGen Laboratory Automation System (Product Code ENGEN) configured with Therm... | Ortho confirmed that it is possible for the mis-association of sample identification and assay re... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | VITROS Chemistry Products URIC Slides, REF/Product Code 194 3927 (300 slides ... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | VITROS Chemistry Products LAC Slides, REF/Product Codes 843 3880 (300 slides ... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | VITROS Chemistry Products GLU Slides, REF/Product Code 170 7801 (300 slides ... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Aug 11, 2016 | VITROS Chemistry Products TRIG Slides, REF/Product Codes 133 6544 (300 slides... | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen o... | Class II | Ortho-Clinical Diagnostics |
| Jul 28, 2016 | VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product... | A field correction was issued by the firm for VITROS TSH reagent lot 5040 due to a higher than ex... | Class III | ORTHO-CLINICAL DIAGNOSTICS |
| Jul 14, 2016 | VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identi... | Ortho Clinical Diagnostics has issued a recall of their VITROS immunodiagnostics Estradiol Reagen... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| Jun 22, 2016 | VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For ... | The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the a... | Class III | Ortho-Clinical Diagnostics |
| Jun 2, 2016 | VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874... | Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic P... | Class II | ORTHO-CLINICAL DIAGNOSTICS |
| May 24, 2016 | VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used ... | Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VI... | Class III | 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.