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 |
|---|---|---|---|---|
| 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 |
| 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 |
| Feb 20, 2014 | VITROS TT4 Calibrator For the quantitative measurement of total thyroxine ... | Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. | 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 |
| 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 |
| Jan 9, 2014 | VITROS Chemistry Products White Reference Slides, White Correction Factor Sli... | An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (fi... | Class II | 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 |
| Oct 4, 2013 | VITROS Chemistry Products COCM Reagent | Inaccurate quality control results. | 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 |
| Jun 12, 2013 | VITROS Chemistry Products CREA 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 THEO 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 URIC 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 UPRO 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 ECO2 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 Ca 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 BuBc 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 LIPA 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 CHE 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 TBIL 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 DGXN 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 Mg 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 Li 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 ALB Slides, 90 slides/pack; catalog number 1988211 ... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products AMYL 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 PHOS 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 |
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.