The Recall Desk

Hazard

Uncertified Device 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
2022-02-23

Of the 1 uncertified device 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 uncertified device 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-0568-2022·2022-02-23

    RNAstill Specimen Collection Kits Recalled Missing FDA 510(k) Clearance

    BASE 10 GENETICS INC is recalling RNAstill Molecular Transport Medium Vials and specimen collection kits nationwide because they lack FDA 510(k) clearance. Approximately 455,791 kits were distributed across 18 states.

    Product
    RNAstill Molecular Transport Medium Vial, Catalog number MTM-001, a component of the following catalog numbers of RNAstill MTM specimen collection kits: MTM-SW03 with Oropharyngeal swab and MTMSW-05 with Nasopharyngeal swab, packaged 25 specimen collection kits per plastic sleev
    Category
    Medical Device
    Distribution
    Distributed nationwide