The Recall Desk

Hazard

Inadequate Validation recalls

8 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2023-11-29

Of the 8 inadequate validation recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all inadequate validation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–8 of 8

  • HighFDA (Devices)·Z-0328-2024·2023-11-29

    Ultrasonic Bronchoscopes Recalled Due to Inadequate Drying Validation

    Aizu Olympus is recalling 823 ultrasonic bronchoscopes (models BF-UC180F, BF-UC190F) because the channel air drying process was not validated, and some repaired units retained water that could cause contamination and infection.

    Product
    Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0218-2023·2022-11-23

    CareFusion GENESIS Sterilization Containers Recalled for Inadequate Aerosol Challenge Testing

    Carefusion 2200 Inc is recalling 562 Genesis STERRAD reusable sterilization containers due to failure to consistently meet aerosol challenge testing requirements, used to sterilize surgical instruments in healthcare facilities.

    Product
    CareFusion V.Mueller GENESIS LARGE, SHALLOW CONT. 28 X 11" (71.1 X 27.9CM) 3" (7.6CM) DEEP, PERFORATED STERRAD COMPATIBLE, REF CD5-3ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1201-2022·2022-06-08

    Swab drug products recalled due to inadequate test method validation

    Busse Hospital Disposables is recalling convenience kits containing swab drug products manufactured by Professional Disposables International due to uncertainty about the adequacy of test methods used in manufacturing.

    Product
    Female SS 3.5MM Pellet Insertion Tray Catalog Number: B9175R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1175-2022·2022-06-08

    Swab and Swabstick Drug Products Recalled for Manufacturing Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International are being recalled due to uncertainty about manufacturing test method validation.

    Product
    Joint Injection Tray Catalog Number: 8561R1
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1171-2022·2022-06-08

    Busse Convenience Kits Recalled: Drug Swabs Face Manufacturing Validation Uncertainty

    Professional Disposables International's swab and swabstick drug products, sold in Busse Convenience kits, are recalled due to uncertainty about whether manufacturing validation test methods were adequate.

    Product
    Nerve Block Tray Catalog Number: 6796R3
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0421-2022·2022-01-05

    FLOWFLEX COVID-19 Rapid Test Recalled for Inadequate Validation

    Migo Trading LLC recalls 200,100 FLOWFLEX COVID-19 rapid self-tests due to inadequate validation and lack of FDA emergency use authorization. The test cannot be reliably used to detect COVID-19 infection.

    Product
    FLOWFLEX SARS-COV-2 Antigen Rapid Test (Self-Testing), 1 Test
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0195-2022·2021-11-10

    Siemens COVID-19 Diagnostic Assay Recalled for Inadequate Validation Data

    Siemens is recalling Atellica IM SARS-CoV-2 Antigen Assay kits because validation data submitted to the FDA was insufficient to confirm the assay's accuracy for its intended use.

    Product
    Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2022·2021-11-10

    ADVIA Centaur SARS-CoV-2 Antigen Assay Recalled for Insufficient Validation Data

    Siemens Healthcare Diagnostics is recalling 261 ADVIA Centaur SARS-CoV-2 Antigen Assay test kits distributed nationwide because the FDA determined that validation data submitted for emergency authorization was insufficient to confirm the assay's effectiveness.

    Product
    ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
    Category
    Medical Device
    Distribution
    Distributed nationwide