The Recall Desk

Hazard

Manufacturing Validation Uncertainty recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2022-06-08

Of the 5 manufacturing 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 manufacturing 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.

1–5 of 5

  • ModerateFDA (Devices)·Z-1173-2022·2022-06-08

    Pump Refill Kit Recalled Over Uncertain Manufacturing Test Method Validation

    Busse Hospital Disposables is recalling Pump Refill Kits nationwide due to uncertainty about whether manufacturing test methods were properly validated. The recall affects 40 units.

    Product
    Pump Refill Kit Catalog Number: 7347R1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1159-2022·2022-06-08

    Single Shot Epidural Tray Recalled Due to Test Validation Uncertainty

    Single Shot Epidural Trays made by Busse Hospital Disposables are being recalled nationwide due to inadequate validation of the test methods used to manufacture the product. The recall affects 400 units.

    Product
    Single Shot Epidural Tray Catalog Number: 8417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1178-2022·2022-06-08

    Procedural Accessory Kit Recalled for Manufacturing Validation Uncertainty

    Busse Hospital Disposables is recalling Procedural Accessory Kits containing swabs due to uncertainty regarding the validation of manufacturing test methods. No illnesses or injuries have been reported.

    Product
    Procedural Accessory Kit Catalog Number: 9665R2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1101-2022·2022-05-25

    Medical Device Swabs Recalled Due to Manufacturing Validation Uncertainty

    Convenience kits containing Prevantics swabs used in medical procedures are being recalled because the manufacturer failed to adequately validate the manufacturing test methods used during production.

    Product
    Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573,
    Category
    Medical Device
    Distribution
    4 states