Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall VITEK MS CLINICAL REAGENT VITEK MS-DS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK MS CLINICAL REAGENT VITEK MS-CHCA As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK MS CLINICAL REAGENT VITEK MS-FA As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL AMIKACIN AK 256 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL BENZYLPENICIL PG 256 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL CEFTRIAXONE TX 32 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL ERTAPENEM ETP 32 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL ERYTHROMYCIN EM 256 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL FLUCONAZOLE FL 256 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL IMIPENEM IP 32 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL LEVOFLOXACIN LE 32 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL MEROPENEM MP 32 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL MINOCYCLINE MC 256 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL RIFAMPICIN RI 32 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL TOBRAMYCIN TM 256 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL VANCOMYCIN VA 256 US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BIOBALL K.RHIZOPHILA As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-GN73 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-GN79 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM INDUSTRY COMBOURG CHROMID CARBA US 20 PLT As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GENE-UP REAGENT GENE-UP LYSIS KIT As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL CEFTOLOZANE/TAZO C/T US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL CEFTAZIDIM/AVIBACTAM US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM CLINICAL CHROMID STREPTO B US 20 PLT As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-GP78 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL ERAVACYCLINE ERV US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-GN99 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GENE-UP REAGENT GENE-UP Salmonella 2 As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-XN09 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL ETEST MEROPENEM MP M100 US As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ETEST CLINICAL ETEST VANCOMYCIN VA M100 US As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS As the temperature and time out of range was exceeded, product performances cannot be guaranteed Class IIFDA’s classJan 11, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 11, 2023ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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