Browse Device Recalls
929 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 929 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 929 FDA device recalls in MO.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 22, 2015 | regard Item Number: 800562, Sterile, NU0651 - Neuro - surgical kit containing... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800415, Sterile, OR0484 - Shoulder System Pk - surgical ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800558, Sterile, OR0647 - Extremity - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880326, Sterile, GS0757 - Major Basin - surgical kit con... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800617, Sterile, NU0768 - Neuro Pk - surgical kit contain... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containi... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880328, Sterile, HT0759 - Pacemaker Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800568, Sterile, OR0658 - Titanium Rib - surgical kit con... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800554001, Sterile, GS0643A - Pediatric Basic - surgical ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number 800565001, Sterile, CV0654A - Pediatric Heart - surgical ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800413001, Sterile, CV0482A - Vascular Pk - surgical kit... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800554002, Sterile, GS0643B - Pediatric Basic - surgical ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800410, Sterile, CV0479 - Open Heart Pk - surgical kit c... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800569001, Sterile, CV0659A - Open Heart A&B - surgical k... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number 800568001, Sterile, OR0658A - Titanium Rib - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800551, Sterile, GS0640 - Lap Chole - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800514, Sterile, LD0592 - C Section Pack - surgical kit c... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800623, Sterile, NU0787 - Neuro - surgical kit containing... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800531, Sterile, NU0615 - Neuro Pk - surgical kit contain... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800550, Sterile, OR0639 - Hip Shoulder - surgical kit con... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit cont... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800566, Sterile, NU0655 - VP Shunt - surgical kit contain... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800597, Sterile, GY0688 - LAVH - surgical kit containing ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit conta... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit con... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit contain... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical k... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit contai... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800553, Sterile, OR0642 - Total Knee - surgical kit conta... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800554, Sterile, GS0643 - Pediatric Basic - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800410001, Sterile, CV0479A - Open Heart Pk - surgical k... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880323, Sterile, LD0754 - C Section - surgical kit conta... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800416, Sterile, GY0485 - Robotic Hysterectomy Pkg - sur... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - surgical ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - surgical kit ... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800408001, Sterile, LD0477A - C-Section Pk - surgical ki... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Apr 22, 2015 | regard Item Number: 800524001, Sterile, LD0608A - C Section - surgical kit co... | The kits contain an equipment glove component which may contain splits or holes compromising the ... | Class II | Resource Optimization & Innovation Llc |
| Mar 27, 2015 | Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton... | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 | Class II | Biomerieux Inc |
| Mar 27, 2015 | Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton,... | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258. | Class II | Biomerieux Inc |
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.