The Recall Desk

Hazard

Lack Of Fda Authorization 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
1
Most recent
2022-03-16

Of the 1 lack of fda authorization recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) 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 authorization 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

  • SevereFDA (Devices)·Z-0716-2022·2022-03-16

    LuSys COVID-19 Antigen Test Kits Recalled for Lack of FDA Authorization

    Lusys Laboratories is recalling 14,745 kits of COVID-19 antigen test kits that lack FDA clearance, approval, or emergency use authorization. The kits were distributed nationwide and internationally without required regulatory validation.

    Product
    LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide