The Recall Desk

Hazard

Missing Premarket Approval recalls

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

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2026-05-13

Of the 1 missing premarket approval 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 missing premarket approval 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.

1–1 of 1

  • ModerateFDA (Devices)·Z-2083-2026·2026-05-13

    One Step UTI in vitro diagnostic test recalled for missing FDA approval

    DFI Co., Ltd. is recalling the One Step UTI in vitro diagnostic test (REF: 3374) because it was distributed without required FDA premarket clearance or approval.

    Product
    One Step UTI in vitro diagnostic test REF: 3374
    Category
    Medical Device
    Distribution
    Distributed nationwide