The Recall Desk

Hazard

Manufacturing Validation Failure 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 manufacturing validation failure 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 manufacturing validation failure 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-1176-2022·2022-06-08

    Core Biopsy Tray Recall Due to Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Core Biopsy Trays (Catalog 8673R4) distributed nationwide because the test methods used to validate manufacturing processes may not have been adequately validated. The affected 285 units may lack proper quality verification.

    Product
    Core Biopsy Tray Catalog Number: 8673R4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1163-2022·2022-06-08

    Busse Hospital Swab Products Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Busse Convenience kits containing swab products due to uncertainty about manufacturing test method validation. No illnesses or injuries have been reported.

    Product
    MBB Tray Catalog Number: 9882
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1147-2022·2022-06-08

    I.V. Start Kit with Swab Products Recalled for Manufacturing Validation Issues

    Busse Hospital Disposables is recalling I.V. Start Kits containing swab products due to inadequate validation of manufacturing test methods. Approximately 2,475 units nationwide may be affected.

    Product
    I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822
    Category
    Medical Device
    Distribution
    Distributed nationwide