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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10826–10850 of 39932

  • HighFDA (Devices)·Z-0787-2023·2023-01-11

    VITEK 2 Reagent GN Test Kit Recalled Due to Storage Condition Exceedance

    Biomerieux Inc. is recalling 348 units of VITEK 2 Reagent GN Test Kit due to temperature and time storage parameter exceedance that may affect diagnostic performance. No illnesses reported.

    Product
    VITEK 2 REAGENT GN TEST KIT VTK2 20 CARDS, CATALOG 21341
    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-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-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-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-0810-2023·2023-01-11

    API JAMES 2AMP Clinical Diagnostic Device Recall Due to Storage Condition Violations

    Biomerieux Inc is recalling API JAMES 2AMP clinical diagnostic devices due to improper temperature and time storage conditions that may affect product performance. Affected units nationwide should not be used.

    Product
    API JAMES 2AMP, CATALOG 70542
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2023·2023-01-11

    FDA Recalls Antibiotic Susceptibility Test Strips Due to Storage Condition Excursion

    Biomerieux Inc is recalling ETEST antibiotic susceptibility test strips due to storage temperature and time excursions that may affect test performance. No illnesses or injuries have been reported.

    Product
    ETEST CLINICAL AMOXI/CLAV 2/1 XL 256 US S30, CATALOG 412240
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2023·2023-01-11

    Guardian Glucose Monitoring App May Automatically Log Out and Block Data Upload

    The Guardian continuous glucose-monitoring app may automatically log out, preventing data uploads and SMS alerts to care partners. This could result in missed detection of dangerous blood sugar levels.

    Product
    Guardian iOS app (MMT-8200) and Guardian Android app (MMT-8201), part of the Guardian 4 system
    Category
    Medical Device
    Distribution
    0 states
  • 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-0881-2023·2023-01-11

    FDA Recalls 9,489 Surgical Instrument Kits for Recalled 3M Drapes

    Windstone Medical Packaging is recalling 9,489 custom surgical instrument kits that contain 3M Steri-Drape Surgical Drapes, which have been recalled by 3M Healthcare. Kits were distributed worldwide and in multiple U.S. states.

    Product
    Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Eye Pack AMS12278B Body Pack AMS12341A Hassan Pack…
    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-0785-2023·2023-01-11

    API 20 C AUX Diagnostic Strips Recalled Due to Storage Temperature Exceedance

    Biomerieux Inc is recalling API 20 C AUX diagnostic strips due to storage conditions that exceeded temperature and time specifications. The manufacturer cannot guarantee product performance.

    Product
    API 20 C AUX 25 STRIPS+25 MEDIA, CATALOG 20210
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0788-2023·2023-01-11

    FDA Recalls VITEK 2 Reagent GP Test Kit Due to Temperature Excursion

    Biomerieux Inc. is recalling VITEK 2 REAGENT GP TEST KIT units nationwide due to temperature and time parameters exceeding acceptable ranges, which may affect test performance.

    Product
    VITEK 2 REAGENT GP TEST KIT VTK2 20 CARDS, CATALOG 21342
    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-0830-2023·2023-01-11

    ETEST Tobramycin Susceptibility Test Recalled for Storage Condition Failure

    Biomerieux is recalling ETEST Clinical Tobramycin susceptibility test strips (batch 1009434160) because temperature and storage time conditions were exceeded during distribution. Product performance cannot be guaranteed due to these storage failures.

    Product
    ETEST CLINICAL TOBRAMYCIN TM 256 US S30, CATALOG 412478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0834-2023·2023-01-11

    VITEK 2 Antimicrobial Susceptibility Test Kits Recalled for Temperature Exposure

    Biomerieux is recalling VITEK 2 AST-GN70 test kits nationwide due to temperature and time excursions that may compromise test performance and diagnostic reliability.

    Product
    VITEK 2 REAGENT AST-GN70 TEST KIT 20 CARDS, CATALOG 413401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2023·2023-01-11

    VITEK 2 AST-GN95 Diagnostic Test Kit Recalled for Performance Failure

    Biomerieux is recalling the VITEK 2 AST-GN95 test kit because storage temperature and time exceeded acceptable limits, preventing performance guarantees. Eighty-four units were distributed nationwide.

    Product
    VITEK 2 REAGENT AST-GN95 TEST KIT 20 CARDS, CATALOG 421982
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2023·2023-01-11

    Measles Antibody Test Kits Recalled Due to Temperature Excursion

    Biomerieux Inc recalled VIDAS Measles IgG diagnostic test kits due to temperature and time excursions during storage or transport. Affected batch 1009421810 distributed nationwide; product performance cannot be guaranteed.

    Product
    VIDAS CLINICAL VIDAS MEASLES IGG 60TESTS, CATALOG 30219
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2023·2023-01-11

    Programmable Diagnostic Computer Software Update Addresses Crash Errors

    Siemens is updating software in 638 Programmable Diagnostic Computers distributed in the US to fix four software errors that could crash the device or corrupt password storage, potentially delaying diagnostics.

    Product
    Programmable Diagnostic Computer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2023·2023-01-11

    Beaver Surgical Eye Knife Recalled for Sterile Barrier Compromise

    Beaver Visitec is recalling its surgical eye knife (Part 376630) used in cataract procedures due to compromised sterile packaging that may lead to infection. Approximately 599 units have been affected in the US.

    Product
    Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2023·2023-01-11

    ETEST Minocycline Susceptibility Test Affected by Storage Temperature Exceedance

    Biomerieux is recalling ETEST CLINICAL MINOCYCLINE MC 256 clinical diagnostic tests nationwide due to storage temperature exceedance that may affect test performance and reliability.

    Product
    ETEST CLINICAL MINOCYCLINE MC 256 US S30, CATALOG 412407
    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-0868-2023·2023-01-11

    VIDAS BRAHMS Procalcitonin Test System Recalled for Storage Condition Failure

    Biomerieux is recalling 47 units of the VIDAS BRAHMS Procalcitonin test system (Batch 1009301530) after determining that temperature and time exceedances compromised product performance. Affected devices may produce unreliable diagnostic results.

    Product
    VIDAS CLINICAL VIDAS BRAHMS PROCALCITONIN 60T, CATALOG 30450-01
    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-0858-2023·2023-01-11

    PPM Lombard TSA Neutralizer Culture Media Recalled for Storage Defect

    Biomerieux is recalling 74 units of PPM Lombard Products TSA 3P neutralizer culture media due to temperature and time storage excursions. Product performance cannot be guaranteed.

    Product
    PPM LOMBARD PRODUCTS TSA 3P W NEUTRALIZERS 100 PLT, CATALOG 423723
    Category
    Medical Device
    Distribution
    Distributed nationwide