Browse Device Recalls
917 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 917 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 917 FDA device recalls in MO.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Mar 27, 2015 | Vitek 2 AST-YS07 REF 414 967, 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 |
| Feb 25, 2015 | Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Ba... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Softwar... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Nov 4, 2014 | Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Softwa... | A software anomaly was identified where the system may automatically transition from "Standby" to... | Class II | Bausch & Lomb Inc |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table, Powered Medical Examination tab... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table with Dual 2 Way Drop Section, Po... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table, Powered Medical Examination tab... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Jul 10, 2014 | Medical Positioning Rapid Response HUT table, Powered Medical Examination tab... | Excessive weight on the table will cause tables with the affected component to drop into the Tren... | Class II | Medical Positioning Inc |
| Feb 10, 2014 | bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medic... | The firm has determined the product may fail to dispense the sample to the agar plate resulting i... | 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.