The Recall Desk

Hazard

Specification Compliance Unknown 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
2026-05-20

Of the 1 specification compliance unknown 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 specification compliance unknown 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-2133-2026·2026-05-20

    On-X Mitral Heart Valve Model ONXMC-25/33 Released Without Complete Testing

    On-X Life Technologies is recalling the On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33, because the valves were distributed before all required testing was complete, preventing confirmation that they meet all release specifications.

    Product
    On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
    Category
    Medical Device
    Distribution
    0 states