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 |
|---|---|---|---|---|
| Nov 9, 2022 | API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS SALMONELLA 60T, CATALOG 30702 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS, CATALOG 413436 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30, CATALOG 419046 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL ETEST MEROPENEM MP M100 US, CATALOG 423786 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS, CATALOG 421051 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS, CATALOG 423425 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT NH TEST KIT VTK2 20 CARDS, CATALOG 21346 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL ERAVACYCLINE ERV US S30, CATALOG 421553 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | BIOBALL B.SPIZIZENII NCTC 10400 550X20, CATALOG 56012 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | ETEST CLINICAL AMIKACIN AK 256 US S30, CATALOG 412218 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT, CATALOG 414012 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Nov 9, 2022 | PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040 | As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Class II | Biomerieux Inc |
| Oct 20, 2022 | ¿regard SHOULDER PK, GS00125U, Item Number 880120021; ortho surgery convenie... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenien... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | ¿regard EYE TRAY, EY00099AE, Item Number 880099031; eye surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard VITRECTOMY PACK, EY00266H, Item Number 800028008; eye surgery convenie... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard SPINE , NU00974F, Item Number 800769006; neuro surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard NEURO TRAY, NU00160R, Item Number 880158018; neuro surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard PEDIATRIC UROLOGY, GS00467J, Item Number 880306010; uro surgery conven... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard SPINE PACK,NU00395J, Item Number 800241010; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard KYPHOPLASTY, OR01101, Item Number 880469; orthopedic surgery convenien... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenienc... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery ... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | ¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery ... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
| Oct 20, 2022 | regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenie... | Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... | Class II | ROi CPS LLC |
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.