The Recall Desk

Hazard

Regulatory Nonconformance recalls

2 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2025-12-17

Of the 2 regulatory nonconformance 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 regulatory nonconformance 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.

1–2 of 2

  • HighFDA (Devices)·Z-0597-2026·2025-12-17

    Fluoroscopy systems recalled after shipping without the source-to-skin distance spacer

    Philips is recalling 110 Azurion R3.0 systems shipped with a FlexArm stand but without the Source-to-Skin Distance spacer needed to meet the FDA minimum 38 cm requirement.

    Product
    Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0875-2026·2025-12-17

    Mammography systems recalled over a missing or incorrect X-ray warning label

    GE Medical Systems is recalling 1,818 Senographe Pristina mammography systems because some have a missing or incorrect X-Ray Warning label.

    Product
    Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
    Category
    Medical Device
    Distribution
    0 states