The Recall Desk

Hazard

Process Validation recalls

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2023-09-06

Of the 2 process 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 process 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.

1–2 of 2

  • HighFDA (Drugs)·D-1112-2023·2023-09-06

    Cardioplegia Solution Recalled for Lack of Sterility Validation

    Central Admixture Pharmacy Services is recalling 786 bags of Cardioplegia Solution del Nido Formula nationwide due to lack of validation data for sanitization cycles, which affects sterility assurance.

    Product
    Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmac
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1704-2022·2022-09-14

    D&C Pack Recall Due to Sterilization Validation Failure

    American Contract Systems is recalling D&C packs that were exposed to multiple sterilization cycles without proper validation. The sterilization failure may compromise device sterility.

    Product
    D&C pack
    Category
    Medical Device
    Distribution
    13 states