The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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10876–10900 of 39932

  • HighFDA (Devices)·Z-0789-2023·2023-01-11

    Medical Device Test Kit Recalled Due to Storage Temperature and Time Excursions

    Biomerieux Inc is recalling 14 units of the VITEK 2 REAGENT YST TEST KIT distributed nationwide because temperature and time excursions during storage may compromise the kit's performance.

    Product
    VITEK 2 REAGENT YST TEST KIT VTK2 20 CARDS, CATALOG 21343
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0838-2023·2023-01-11

    Medical device test kit recalled due to storage temperature and time excursion

    Biomerieux Inc is recalling the VITEK 2 REAGENT AST-GN81 Test Kit after storage conditions exceeded specified ranges, preventing guaranteed product performance. The recall affects 34 units distributed nationwide.

    Product
    VITEK 2 REAGENT AST-GN81 TEST KIT 20 CARDS, CATALOG 413438
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2023·2023-01-11

    VITROS Intact PTH Reagent Pack recalled for negatively biased measurement results

    Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.

    Product
    VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2023·2023-01-11

    ETEST Clinical Meropenem Susceptibility Test Recalled for Storage Condition Failure

    Biomerieux is recalling 3 units of ETEST Clinical Meropenem MP 32 susceptibility test (catalog 412401) nationwide due to storage temperature and time exceedances that cannot guarantee product performance.

    Product
    ETEST CLINICAL MEROPENEM MP 32 US S30, CATALOG 412401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2023·2023-01-11

    ETEST Clinical Erythromycin test plates recalled for storage temperature deviation

    Biomerieux Inc is recalling ETEST Clinical Erythromycin EM 256 US S30 test plates (batch 1009157090) distributed nationwide. Product performance cannot be guaranteed due to temperature and time storage conditions that exceeded specifications.

    Product
    ETEST CLINICAL ERYTHROMYCIN EM 256 US S30, CATALOG 412333
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2023·2023-01-11

    VERIFY Steam Test Pack Biological Indicators May Fail to Detect Sterilization Failure

    Steris is recalling VERIFY Steam Test Packs because biological indicators in affected lots may fail to correctly monitor steam and ethylene oxide sterilization, potentially allowing failed sterilization to go undetected.

    Product
    VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0848-2023·2023-01-11

    VITEK 2 Diagnostic Test Kit Recalled for Storage Parameter Exceedance

    Biomerieux is recalling 39 units of a diagnostic test kit because storage temperature and time parameters were exceeded, which may affect test performance and reliability.

    Product
    VITEK 2 REAGENT AST-ST02 TEST KIT 20 CARDS, CATALOG 420915
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2023·2023-01-11

    Medical Diagnostic Reagent Recalled Due to Storage Temperature Damage

    Biomerieux Inc is recalling PREVI COLOR GRAM diagnostic reagent (Catalog 29586) distributed nationwide because improper storage conditions may have degraded product performance.

    Product
    PREVI COLOR GRAM REAGENT IODINE-B (NA), CATALOG 29586
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2023·2023-01-11

    TEMPO Control Kit Reagents Recalled Due to Storage Temperature Excursion

    Biomerieux is recalling TEMPO REAGENTS TEMPO CONTROL KIT (catalog 80000) due to storage conditions exceeding temperature and time limits, compromising product performance. Batch 1009477900 was distributed nationwide.

    Product
    TEMPO REAGENTS TEMPO CONTROL KIT , CATALOG 80000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2023·2023-01-11

    Clinical Diagnostic Device Recall: ETEST Rifampicin RI 32 Performance Degradation

    Biomerieux Inc is recalling ETEST CLINICAL RIFAMPICIN RI 32 clinical diagnostic strips because temperature and time storage parameters were exceeded, and product performance cannot be guaranteed.

    Product
    ETEST CLINICAL RIFAMPICIN RI 32 US S30, CATALOG 412449
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0855-2023·2023-01-11

    Medical Device Reagent Recalled for Temperature Storage Condition Failure

    Biomerieux Inc recalls GENE-UP Salmonella 2 reagent (Batch 1009407250) after storage temperature and time limits were exceeded, preventing performance guarantee.

    Product
    GENE-UP REAGENT GENE-UP Salmonella 2, CATALOG 423105
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0786-2023·2023-01-11

    Diagnostic Test Kit Recalled Due to Exceeded Storage Conditions

    Biomerieux Inc is recalling API STAPH 25 diagnostic test kits because storage conditions exceeded safe temperature and time parameters. Product performance cannot be guaranteed for the affected batch.

    Product
    API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0849-2023·2023-01-11

    Microbiological susceptibility test strips recalled for temperature and time excursion

    Biomerieux Inc. is recalling ETEST Clinical Imipenem Relebactam test strips (Catalog 420927) distributed nationwide because the product experienced temperature and time excursions during storage. The manufacturer cannot guarantee the product's test performance.

    Product
    ETEST CLINICAL IMIPENEM RELEBACTAM IPR US S30, CATALOG 420927
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0800-2023·2023-01-11

    VIDAS Quality Control Product Recalled for Storage Condition Deviation

    Biomerieux Inc is recalling VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T nationwide due to storage temperature and time deviations that prevent performance guarantee. Batch 1009351560 is affected.

    Product
    VIDAS CLINICAL QCV-QUALITY CONTROL VIDAS 60T, CATALOG 30706
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0864-2023·2023-01-11

    VIDAS HCG 60 Clinical Test Kits Recalled for Exceeded Storage Conditions

    Biomerieux Inc is recalling VIDAS HCG 60 test kits because storage conditions were exceeded, which cannot guarantee product performance. No illnesses or injuries have been reported.

    Product
    VIDAS CLINICAL VIDAS HCG 60 TESTS, CATALOG 30405-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0872-2023·2023-01-11

    Biomerieux Culture Media Recalled Due to Temperature and Time Excursions

    Biomerieux Inc is recalling diagnostic culture media because temperature and time storage conditions exceeded acceptable specifications, which means product performance cannot be guaranteed.

    Product
    PPM LOMBARD PRODUCTS CT&TI-TSA + L & P80 10PLT, CATALOG C6045-TI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0802-2023·2023-01-11

    CHROMID MRSA Culture Medium Recalled for Storage Temperature Exceedance

    Biomerieux Inc is recalling PPM CLINICAL CHROMID MRSA 20 PLT diagnostic culture media (84 units) due to temperature and time exceedance during storage that may compromise product performance.

    Product
    PPM CLINICAL CHROMID MRSA 20 PLT US, CATALOG 43841
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0790-2023·2023-01-11

    VITEK 2 BCL Test Kit recalled for storage condition violations

    A batch of VITEK 2 Reagent BCL Test Kit from Biomerieux Inc is being recalled because storage conditions were exceeded, and product performance cannot be guaranteed.

    Product
    VITEK 2 REAGENT BCL TEST KIT VTK2 20 CARDS, CATALOG 21345
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0803-2023·2023-01-11

    PPM Clinical Chromid VRE Culture Media Recalled for Storage Excursion

    Biomerieux is recalling PPM Clinical Craponne Chromid VRE culture media because storage conditions (temperature and time) exceeded specifications. Batch 1009540400 was distributed nationwide in the United States.

    Product
    PPM CLINICAL CRAPONNE CHROMID VRE 20 PLT US, CATALOG 43851
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0852-2023·2023-01-11

    Medical Device Recall: ETEST Meropenem/Vaborbactam Due to Storage Temperature Excursion

    Biomerieux is recalling 6 units of ETEST Meropenem/Vaborbactam susceptibility test kits (Batch 1008848690) distributed nationwide because they were stored outside specified temperature and time ranges, preventing guarantee of product performance.

    Product
    ETEST CLINICAL ETEST MEROPENEM/VABORBACTAM MEV US S30, CATALOG 421560
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0863-2023·2023-01-11

    ETEST Clinical Colistin Test Product Recalled Due to Storage Conditions

    Biomerieux Inc is recalling ETEST Clinical Colistin diagnostic test products because storage conditions exceeded safe parameters, making product performance unreliable. Affected batches were distributed nationwide.

    Product
    ETEST CLINICAL COLISTIN CO 256 US B100, CATALOG 537348
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0777-2023·2023-01-11

    Beckman Coulter IRISpec glucose control false positive results with urine chemistry strips

    Beckman Coulter is recalling IRISpec glucose control due to intermittent false positive results when used with specific urine chemistry strips. The recall may affect laboratory test accuracy.

    Product
    BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0844-2023·2023-01-11

    Laboratory Culture Medium Recalled Due to Storage Condition Failure

    Biomerieux Inc is recalling PPM Lombard Products IRR Count-Tact 3P Agar because storage conditions exceeded acceptable temperature and time parameters, potentially compromising product performance.

    Product
    PPM LOMBARD PRODUCTS IRR COUNT-TACT 3P AGAR 100 PLT, CATALOG 418049
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0842-2023·2023-01-11

    PPM Clinical CHROMID MRSA diagnostic product recalled due to storage condition exceedance

    Biomerieux Inc is recalling a batch of PPM Clinical CHROMID MRSA diagnostic medium (catalog 414524) after storage temperatures and timeframes exceeded specification, preventing performance guarantees.

    Product
    PPM CLINICAL CHROMID MRSA S AUREUS 20PLT US, CATALOG 414524
    Category
    Medical Device
    Distribution
    Distributed nationwide