The Recall Desk

Hazard

Outer Sheath Detachment 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
2025-02-05

Of the 1 outer sheath detachment 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 outer sheath detachment 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

  • HighFDA (Devices)·Z-1027-2025·2025-02-05

    AXIOS Stent Delivery System Outer Sheath May Detach During Use

    The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.

    Product
    AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670
    Category
    Medical Device
    Distribution
    Distributed nationwide