The Recall Desk

Hazard

Unapproved Component 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
1
Most recent
2025-04-23

Of the 2 unapproved component 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 (50%) 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 unapproved component 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

  • SevereFDA (Devices)·Z-1558-2025·2025-04-23

    Welch Allyn Connex Vital Signs Monitors with Unapproved Batteries

    Baxter Healthcare is recalling Welch Allyn Connex Vital Signs Monitors because some units experienced battery-related fires caused by unapproved third-party after-market batteries.

    Product
    Welch Allyn Connex Vital Signs Monitor (CVSM):
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1261-2023·2023-03-22

    TEMA Axle Small elbow prosthesis recalled due to unapproved component

    Limacorporate recalled 5 TEMA Axle Small elbow prostheses due to inclusion of a component not cleared for U.S. marketing. Affected systems were distributed to Texas.

    Product
    TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
    Category
    Medical Device
    Distribution
    1 state