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 deaths or serious injuries are reported, 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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10126–10150 of 13717

  • HighFDA (Devices)·Z-0847-2023·2023-01-11

    Medical Laboratory Diagnostic Media Recalled Due to Storage Condition Violations

    Biomerieux Inc. is recalling PPM CLINICAL CHROMID STREPTO B diagnostic media (batch 1009534170) because storage temperature and time exceeded specified limits, preventing assurance of product performance.

    Product
    PPM CLINICAL CHROMID STREPTO B US 20 PLT, CATALOG 419751
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0801-2023·2023-01-11

    Medical device diagnostic plates recalled for storage condition violations

    Biomerieux Inc is recalling PPM Clinical Chromid Candida diagnostic plates because storage temperature and time parameters were exceeded, preventing performance guarantees.

    Product
    PPM CLINICAL CRAPONNE CLINICAL CHROMID CANDIDA 20 PLATES, CATALOG 43631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0792-2023·2023-01-11

    VITEK 2 AST-GP67 Reagent Test Kit Recalled Due to Storage Condition Excursion

    Biomerieux Inc. is recalling VITEK 2 Antibiotic Susceptibility Test Kits (AST-GP67) due to storage temperature and time conditions exceeding acceptable limits, which cannot guarantee product performance.

    Product
    VITEK 2 REAGENT AST-GP67 TEST KIT 20 CARDS, CATALOG 22226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2023·2023-01-11

    ETEST Clinical Vancomycin Test Kits Recalled Due to Storage Damage

    Biomerieux Inc is recalling 7 units of ETEST Clinical Vancomycin VA 256 test kits due to storage temperature excursions that may compromise test performance. Affected kits were distributed nationwide.

    Product
    ETEST CLINICAL VANCOMYCIN VA 256 US S30, CATALOG 412486
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2023·2023-01-11

    Biomerieux VIDAS RUB IGG Tests Recalled Due to Storage Conditions

    Biomerieux is recalling VIDAS RUB IGG diagnostic tests nationwide after storage temperature and duration exceeded specifications, affecting product performance guarantees.

    Product
    VIDAS CLINICAL VIDAS RUB IGG 60 TESTS, CATALOG 30226
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0795-2023·2023-01-11

    VIDAS Varicel Zoster IGG 60T Recalled Due to Storage Condition Excursion

    Biomerieux Inc is recalling VIDAS Varicel Zoster IGG 60T (Catalog 30217, Batch 229478) due to storage temperature and time exceedance. The recalled units cannot be guaranteed to perform accurately.

    Product
    VIDAS CLINICALVIDAS VARICEL. ZOSTER IGG 60 T, CATALOG 30217
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0879-2023·2023-01-11

    Detect COVID-19 Test may produce false negative results in affected lots

    Detect Headquarters is recalling specific lots of Detect COVID-19 Test (Model 21205) due to risk of false negative results. Affected tests may fail to detect COVID-19 infection, potentially delaying treatment and increasing community spread.

    Product
    Detect Covid-19 Test Product/Model Number: 21205
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2023·2023-01-11

    Laboratory quality control material with degraded potency affecting diagnostic verification

    Randox Liquid Assayed Specific Protein Control Level 2 has lost potency in rheumatoid factor, causing laboratory quality control tests to fail and delaying patient test results.

    Product
    Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2023·2023-01-11

    Listeria Detection Test Strips Recalled for Unreliable Performance

    Biomerieux is recalling API Listeria detection test strips that were exposed to temperature and time exceedance during storage. Product performance cannot be guaranteed as a result.

    Product
    API LISTERIA 10 STRIPS+10 MEDIA, CATALOG 10300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2023·2023-01-11

    Nephrocheck Liquid Control Reagent Recall Due to Storage Condition Violation

    Biomerieux is recalling one batch of Nephrocheck Liquid Control Reagent because the product was stored outside proper temperature and time parameters, making performance unreliable.

    Product
    ASTUTE REAGENT NEPHROCHECK LIQUID CONTROLS KIT US, CATALOG 500013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2023·2023-01-11

    Clinical reagent recalled due to temperature and time excursion

    Biomerieux Inc is recalling VITEK MS CLINICAL REAGENT VITEK MS-CHCA due to temperature and time excursions that may prevent product performance guarantees. No illnesses reported.

    Product
    VITEK MS CLINICAL REAGENT VITEK MS-CHCA, CATALOG 411071
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0812-2023·2023-01-11

    FDA Recalls ASTUTE Electronic Quality Control Device for Storage Condition Excursion

    Biomerieux Inc. is recalling ASTUTE electronic quality control devices due to temperature and time storage excursion that may compromise product performance in laboratory settings.

    Product
    ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0837-2023·2023-01-11

    VITEK 2 Antibiotic Susceptibility Test Kits Recalled for Storage Condition Exceedance

    Biomerieux is recalling VITEK 2 REAGENT AST-GN80 test kits due to temperature and time excursions during storage or handling. Product performance cannot be guaranteed for affected units.

    Product
    VITEK 2 REAGENT AST-GN80 TEST KIT 20 CARDS, CATALOG 413437
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2023·2023-01-11

    Biomerieux VITEK MS Clinical Reagent Recall Due to Temperature Excursion

    Biomerieux is recalling VITEK MS-DS clinical reagent due to temperature and time conditions that exceeded specification. Thirteen units distributed nationwide cannot guarantee product performance.

    Product
    VITEK MS CLINICAL REAGENT VITEK MS-DS, CATALOG 410893
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2023·2023-01-11

    Randox Protein Control Material Concentration Decreased, Affecting Quality Control

    Randox Laboratories is recalling Liquid Assayed Specific Protein Control Level 3 (catalog PS2684) because the concentration of rheumatoid factor has decreased, causing quality control systems to run outside acceptable ranges and delaying test result reporting.

    Product
    Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0798-2023·2023-01-11

    VIDAS Listeria 60T Clinical Diagnostic Test Kit Recalled for Storage Failure

    Biomerieux recalls VIDAS Listeria 60T test kits (Batch 1009371140) distributed nationwide because storage conditions were exceeded and product performance cannot be guaranteed. Users should discontinue use and contact the manufacturer.

    Product
    VIDAS CLINICAL VIDAS LISTERIA 60T, CATALOG 30700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0843-2023·2023-01-11

    FDA Recalls VITEK 2 AST-GP75 Test Kits for Storage Condition Violations

    Biomerieux Inc recalled 218 units of VITEK 2 AST-GP75 diagnostic test kits due to storage temperature and time violations that compromise test reliability. Affected facilities should stop using the recalled kits.

    Product
    VITEK 2 REAGENT AST-GP75 TEST KIT 20 CARDS, CATALOG 415670
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2023·2023-01-11

    VITEK 2 AST-XN15 Test Kit Recalled for Temperature and Time Storage Failure

    Biomerieux Inc. recalls 58 units of the VITEK 2 AST-XN15 Test Kit after storage temperatures exceeded safe limits. Performance cannot be guaranteed. Nationwide US distribution.

    Product
    VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2023·2023-01-11

    FDA Recalls VITEK 2 Antibiotic Susceptibility Test Kits Due to Storage Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT AST-GN69 test kits nationwide due to temperature and time excursions during storage that may compromise product performance.

    Product
    VITEK 2 REAGENT AST-GN69 TEST KIT 20 CARDS, CATALOG 413400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2023·2023-01-11

    Medical Device Reagent Recall Due to Storage Condition Exceedance

    Biomerieux is recalling DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 reagent kits because temperature and time storage conditions were exceeded, preventing performance guarantees. Distributed nationwide, affected units should be removed from service.

    Product
    DCOUNT SYSTEMS REAGENTS CHEMCHROME V14 (6X1.8ML), CATALOG 306-R1026-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2023·2023-01-11

    API VP1 VP2 Medical Reagents Recalled for Storage Condition Failure

    Biomerieux Inc is recalling API VP1 VP2 reagents (Catalog 70422) nationwide because storage temperature and time limits were exceeded, preventing the manufacturer from guaranteeing product performance.

    Product
    API VP1 VP2 REAGENTS, CATALOG 70422
    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-0856-2023·2023-01-11

    Medical Device Test Kit Recalled Due to Storage Condition Exceedance

    Biomerieux Inc. is recalling the VITEK 2 REAGENT AST-N801 TEST KIT nationwide due to storage conditions exceeding acceptable ranges, which cannot guarantee product performance.

    Product
    VITEK 2 REAGENT AST-N801 TEST KIT 20 CARDS, CATALOG 423416
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0774-2023·2023-01-11

    Disposable Trocars Lack Printed Expiration Dates on Packaging

    ENDO Pharmaceuticals is recalling 2,603 disposable trocars because packaging does not include printed expiration dates, creating risk of use of expired sterile devices.

    Product
    9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2023·2023-01-11

    FDA Recalls ETEST Fluconazole Susceptibility Test due to Storage Excursion

    Biomerieux Inc. is recalling ETEST CLINICAL FLUCONAZOLE FL 256 susceptibility testing kits due to storage temperature and time excursions that prevent performance verification. Affected batch 1009172020 is distributed nationwide.

    Product
    ETEST CLINICAL FLUCONAZOLE FL 256 US S30, CATALOG 412333
    Category
    Medical Device
    Distribution
    Distributed nationwide