The Recall Desk

Hazard

Test Method Validation 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 test method 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.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all test method 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.

1–4 of 4

  • ModerateFDA (Devices)·Z-1153-2022·2022-06-08

    Swab Drug Products Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Convenience kits containing swab/swabstick drug products manufactured by Professional Disposables International (PDI) are being recalled due to uncertainty about the adequacy of test method validation used in manufacturing.

    Product
    Epidural Tray Catalog 1307
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1168-2022·2022-06-08

    Cervical Tray Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Hospital Disposables is recalling Cervical Tray Catalog Number 3765R2 units containing swab products due to uncertainty about the adequacy of manufacturing test method validation. Lot Numbers 2031213S and 2130221S are affected.

    Product
    Cervical Tray Catalog Number: 3765R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1182-2022·2022-06-08

    Busse Convenience Kits Recalled for Manufacturing Test Method Validation Uncertainty

    Busse Convenience kits containing swab and swabstick products manufactured by Professional Disposables International are recalled by the FDA due to uncertainty regarding the validation of manufacturing test methods.

    Product
    SS 3.5Mm Pellet Insertion Tray with large Gloves Catalog Number: B1352R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0571-2022·2022-03-02

    Prevantics Swab Drug Recall for Test Method Validation Deficiency

    Professional Disposables International, Inc. is recalling Prevantics Swab (chlorhexidine gluconate and isopropyl alcohol) due to cGMP deviations involving inadequate validation of manufacturing test methods. The product was distributed nationwide in the USA and Puerto Rico.

    Product
    PREVANTICS SWAB — PREVANTICS SWAB (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide