The Recall Desk

Hazard

Thermal Incident recalls

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

What the numbers show

Total
4
Critical
0
Severe
1
Most recent
2025-06-18

Of the 4 thermal incident 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 (25%) 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 thermal incident 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.

1–4 of 4

  • SevereFDA (Devices)·Z-1921-2025·2025-06-18

    SOLTIVE Premium SuperPulsed Laser System surgical instrument thermal incident

    Olympus is recalling the SOLTIVE Premium SuperPulsed Laser System due to risk of thermal incidents including smoke, sparks, burning, or flames during clinical use caused by fiber fracturing.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium SuperPulsed Laser System Model/Catalog Number: TFL-PLS, TFL-PLS-JA (Japan only); Software Version: N/A Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1923-2025·2025-06-18

    Soltive Reusable Laser Fibers Recalled for Thermal Incident Risk

    Olympus Corporation of the Americas is recalling Soltive Reusable Laser Fibers due to risk of thermal incidents including smoke, sparks, burning, or unsteady flames during surgery, caused by fiber fracturing.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1920-2025·2025-06-18

    SOLTIVE Pro SuperPulsed Laser System surgical instrument thermal incident

    Olympus Corporation of the Americas is recalling the SOLTIVE Pro SuperPulsed Laser System due to risk of unexpected smoke, sparks, burning, or unsteady flames caused by fiber fracturing during clinical use.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only); Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1922-2025·2025-06-18

    Soltive SuperPulsed Laser Fibers recalled for thermal incident risk

    Olympus Corporation of the Americas is recalling Soltive SuperPulsed Laser Fibers due to potential fiber fracturing that can cause thermal incidents including smoke, sparks, burning, or unsteady flames during clinical use.

    Product
    Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only
    Category
    Medical Device
    Distribution
    Distributed nationwide