The Recall Desk

Hazard

Improper 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
2025-01-29

Of the 1 improper 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 improper 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-0970-2025·2025-01-29

    Otological Ventilation Tube Recalled Due to Lack of FDA Clearance

    Adept Medical Ltd is recalling otological ventilation tubes distributed without FDA 510(k) clearance. The recall affects 4,080 units distributed in the US and internationally.

    Product
    Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;
    Category
    Medical Device
    Distribution
    Distributed nationwide