The Recall Desk

Hazard

Lack Of Fda 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 lack of fda 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 lack of fda 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-2085-2026·2026-05-13

    QUCARE Total Cholesterol in vitro Diagnostic Test Recalled

    DFI Co., Ltd. is recalling QUCARE Total Cholesterol in vitro diagnostic test devices because they were distributed without required FDA premarket clearance or approval.

    Product
    QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
    Category
    Medical Device
    Distribution
    Distributed nationwide