The Recall Desk

Hazard

Validation Uncertainty recalls

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

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2022-06-08

Of the 4 validation uncertainty 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 validation uncertainty 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.

1–4 of 4

  • HighFDA (Devices)·Z-1152-2022·2022-06-08

    Busse Single Shot Epidural Tray recalled for test method validation uncertainty

    Busse Hospital Disposables is recalling Single Shot Epidural Trays nationwide due to uncertainty about the adequacy of test method validation used to manufacture swab components. The FDA classified this as a Class II recall.

    Product
    Single Shot Epidural Tray Catalog 1292
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1155-2022·2022-06-08

    Swab Drug Products Recalled Due to Manufacturing Validation Uncertainty

    Convenience kits containing swab/swabstick drug products are being recalled due to uncertainty about whether test methods used during manufacturing adequately validated the products. Affected products include 80 units distributed nationwide.

    Product
    Epidural Tray Catalog 1577
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1165-2022·2022-06-08

    Stereo Breast Biopsy Tray Recalled for Manufacturing Test Validation Uncertainty

    Busse Hospital Disposables recalls stereo breast biopsy trays due to uncertainty about the adequacy of manufacturing test validation. The recall affects 23 units distributed nationwide.

    Product
    Stereo Breast Biopsy Tray Catalog Number: 2383R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1179-2022·2022-06-08

    Busse swab and swabstick products recalled for validation uncertainty

    Busse Convenience kits containing swab and swabstick drug products are recalled nationwide due to uncertainty about whether manufacturing test methods were adequately validated.

    Product
    3.2MM Pellet Insertion Tray Catalog Number: B1144
    Category
    Drug
    Distribution
    Distributed nationwide