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 12, 2013 | VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 105318... | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry... | Class II | Ortho-Clinical Diagnostics |
| Jun 12, 2013 | VITROS Chemistry Products SALI 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 PROT 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 6, 2013 | Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375,... | Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incuba... | Class II | Ortho-Clinical Diagnostics |
| May 9, 2013 | VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number... | While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant ... | Class III | Ortho-Clinical Diagnostics |
| May 9, 2013 | VITROS Chemistry Products CRP Slides (Reagent), REF/Catalog Number 192 6740 a... | While performing interval testing Ortho Clinical Diagnostics (OCD) determined that an excess amou... | Class III | Ortho-Clinical Diagnostics |
| May 6, 2013 | VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage:... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member)(product cod... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | VITROS 5600 Integrated System (product code 6802413) Product Usage: For ... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | 1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 F... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| May 6, 2013 | ORTHO¿ Assay Software (OAS) Server, Catalog # 6842840 Usage: The ORTHO¿ S... | There is evidence that an electrical short within the systems connector has caused an accumulatio... | Class II | Ortho-Clinical Diagnostics |
| Apr 3, 2013 | VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho... | Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 de... | Class III | Ortho-Clinical Diagnostics |
| Apr 1, 2013 | VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 680... | The firm is recalling the specific lot due to lower than expected results. | Class II | Ortho-Clinical Diagnostics |
| Mar 14, 2013 | VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For t... | Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outlie... | 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 |
| Dec 13, 2012 | Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartri... | Some VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly co... | Class II | Ortho-Clinical Diagnostics |
| Nov 1, 2012 | VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B sur... | Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an ina... | Class III | Ortho-Clinical Diagnostics |
| Jun 28, 2012 | VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged... | Ortho Clinical Diagnostics revised the VITROS Chemistry Products DGXN Slides Instructions for Use... | Class II | Ortho-Clinical Diagnostics |
| May 21, 2012 | VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi ... | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... | Class II | Ortho-Clinical Diagnostics |
| May 21, 2012 | VITROS 4600 Chemistry System Software For use in the in-vitro quantitativ... | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... | Class II | Ortho-Clinical Diagnostics |
| May 21, 2012 | VITROS 5600 Integrated System Software For use in the in-vitro quantitati... | software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent ... | 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.