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Browse Device Recalls

368 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 368 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 368 FDA device recalls.

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DateProductReasonClassFirm
Nov 9, 2022 API NIT1 NIT2 REAGENTS, CATALOG 70442 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-GN99 TEST KIT 20 CARDS, CATALOG 423102 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-ST02 TEST KIT 20 CARDS, CATALOG 420915 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 PREVI COLOR GRAM REAGENT NOZZLE CLEANING SOLUTION (NA), CATALOG 29588 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 ETEST CLINICAL IMIPENEM IP 32 US S30, CATALOG 412373 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 GENE-UP REAGENT GENE-UP LYSIS KIT, CATALOG 414057 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 S AUREUS 20PLT US, CATALOG 414524 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 LPT BROTH (4X3L), CATALOG 410849 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706 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 R2A MEDIUM 10PLT, CATALOG M1065 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 ETEST CLINICAL CEFTRIAXONE TX 32 US S30, CATALOG 412302 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
Nov 9, 2022 GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105 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 CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI 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 CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631 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 419014 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-GP75 TEST KIT 20 CARDS, CATALOG 415670 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-GN81 TEST KIT 20 CARDS, CATALOG 413438 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class II Biomerieux Inc
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
Dec 20, 2021 API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualita... Risk of misidentification or delayed results with the absence of identification due to thermoform... Class II Biomerieux Inc
Nov 9, 2021 RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in... There is an error in the new version of the package insert. The Reading Table lists the incorrec... Class II Biomerieux Inc
Jun 24, 2021 ETEST IMIPENEM RELEBACTAM. in vitro diagnostic Major errors (Resistant result instead of Susceptible result) were observed with Pseudomonas aeru... 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.