Browse Device Recalls
2,437 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,437 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 2,437 FDA device recalls in 2013.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized ... | Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because ... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only... | The affected fixed rod holders did not allow the instrument to lock down on the spinal rod. | Class II | PIONEER SURGICAL TECHNOLOGY, INC. |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 14, 2013 | bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITE... | A product issue has been identified for customers using software version 6.01 and are interfaced ... | Class II | Biomerieux Inc |
| Jun 13, 2013 | Discovery NM 630, dual detector free-geometry integrated nuclear imaging syst... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Cam... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\ki... | In vitro diagnostic test kit may exhibit invalid internal negative control results. | Class II | Becton Dickinson & Co. |
| Jun 13, 2013 | Brivo NM615, is an all-purpose, single detector integrated nuclear imaging sy... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intend... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging sy... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is inten... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| Jun 13, 2013 | Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera... | GE became aware of an incident at a VA Medical Center facility in the US in which a patient died ... | Class I | GE Healthcare, LLC |
| 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 | Synthes CMF Distraction System The product is intended for use as a bone s... | The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxill... | Class II | Synthes USA HQ, Inc. |
| 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 | Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, ... | Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. ... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| 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 |
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.