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Browse Device Recalls

916 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 916 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 916 FDA device recalls in MO.

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DateProductReasonClassFirm
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
Oct 20, 2022 regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery conve... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SPINE, OR01100A, Item Number 880468001; 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 SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery c... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenienc... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208 Specific lots of FLXfit implants have internal components that may have been manufactured using s... Class II CoreLink LLC
Oct 20, 2022 regard SHOULDER, GS00828G, Item Number 880367007; 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 ACDF, NU00698H, Item Number 800246008; 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 MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenie... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; orth... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho sur... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery c... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery conveni... Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently ... Class II ROi CPS LLC
Oct 20, 2022 regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro 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.