Browse Device Recalls
126 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 126 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 126 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 |
| 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 |
| May 18, 2016 | VITROS Chemistry Products Ca Slides, GEN 29, REF/Product Code 145 0261, Uniqu... | Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be gene... | Class II | Ortho-Clinical Diagnostics |
| May 9, 2016 | VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784,... | Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products... | Class III | ORTHO-CLINICAL DIAGNOSTICS |
| Apr 6, 2016 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in... | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... | Class II | Ortho-Clinical Diagnostics |
| Apr 6, 2016 | VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifi... | Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 ... | Class II | Ortho-Clinical Diagnostics |
| Sep 28, 2015 | VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 85... | The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes ... | Class III | Ortho-Clinical Diagnostics |
| 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 |
| Nov 19, 2014 | VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Nu... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Nov 19, 2014 | VITROS 3600 Immunodiagnostic System, Catalog Number 6802783, IVD --- Ortho C... | Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and ... | Class II | Ortho-Clinical Diagnostics |
| Sep 8, 2014 | VITROS 5600 Integrated System, System Product Code 6802413. For use in the... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Sep 8, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), System Pro... | Ortho Clinical Diagnostics (OCD) identified an anomaly with Software Version 3.0 and below on the... | Class II | Ortho-Clinical Diagnostics |
| Aug 20, 2014 | VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671,... | Ortho Clinical Diagnostics identified a potential for biased results to be generated when using V... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | VITROS 5600 Integrated System --- For use in the in vitro quantitative, semi-... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member) --- The VIT... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | Class II | Ortho-Clinical Diagnostics |
| Jul 7, 2014 | VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative,... | Ortho Clinical Diagnostics has identified an anomaly with VITROS System Software Version 3.0 and ... | 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 20, 2014 | enGen (TM) Laboratory Automation System configured with Data Innovations, LLC... | Software Anomaly: Ortho Clinical Diagnostics (OCD) has become aware that if a sample requires fol... | Class II | Ortho-Clinical Diagnostics |
| Jan 15, 2014 | VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATAL... | Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin... | Class III | Ortho-Clinical Diagnostics |
| Oct 25, 2013 | VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic P... | Class II | Ortho-Clinical Diagnostics |
| Oct 17, 2013 | VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Di... | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator K... | Class II | Ortho-Clinical Diagnostics |
| Oct 17, 2013 | VITROS Chemistry Products Na+ Slides, manufactured by Ortho Clinical Diagnost... | Ortho Clinical Diagnostics has recalled VITROS Chemistry Products Na+ Slides and the Calibrator K... | Class II | Ortho-Clinical Diagnostics |
| Oct 10, 2013 | VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chem... | Ortho Clinical Diagnostics issued a product correction notification for VITROS Chemistry Mixing C... | Class II | Ortho-Clinical Diagnostics |
| Oct 9, 2013 | VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/... | Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic P... | Class II | Ortho-Clinical Diagnostics |
| Oct 8, 2013 | enGen Track System with enGen Custom v3.2.2 (& below) Product The VITROS 5... | Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen S... | Class II | Ortho-Clinical Diagnostics |
| Oct 8, 2013 | enGen Track System with enGen Select v5.0 with autoverification enabled Pr... | Ortho Clinical Diagnostics issued an Urgent Product Correction Notification involving the enGen S... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products LAC Slides packaged as 300 slides/pack catalog numb... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog numb... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products PHBR Slides packaged as 90 slides/pack catalog numb... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products dHDL Slides packaged as 300 slides/pack catalog num... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog num... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products CRBM Slides packaged as 90 slides/pack catalog numb... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog numbe... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products AMON Slides packaged as 300 slides/pack catalog num... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products AcP Slides, 90 slides/pack; catalog number 8168122 ... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog numb... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products ALC Slides, 90 slides/pack; catalog number 8046872 ... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog num... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products ACET Slides, 90 slides/pack; catalog number 1037274... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products PHYT Slides packaged as 90 slides/pack catalog numb... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products CK-MB Slides packaged as 300 slides/pack catalog nu... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products CRP Slides packaged as 90 slides/pack catalog numbe... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products Fe Slides packaged as 300 slides/pack catalog numbe... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | 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.