The Recall Desk

Hazard

Oct Imaging 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
2026-04-22

Of the 1 oct imaging 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 oct imaging 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-1823-2026·2026-04-22

    Gentuity HF-OCT imaging systems may repeat frames during catheter pullback

    Gentuity is issuing a correction for HF-OCT Imaging Systems because frames may repeat during pullback with Vis-Rx catheters, affecting longitudinal length measurements.

    Product
    Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13;
    Category
    Medical Device
    Distribution
    Distributed nationwide