Agency classClass IIOur severity:High FDA (Devices)·Z-1923-2025·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall involving risk-of-harm products (thermal incidents including burns and fire hazards) where injury has not yet been reported, meeting the rubric criterion for a High severity score.

Plain-English summary

Olympus Corporation of the Americas is recalling Soltive Reusable Laser Fibers (models TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, and Japan-specific variants) due to a potential for thermal incidents during clinical use. The hazard includes unexpected occurrence of smoke, sparks, burning, or unsteady flames, caused by fracturing of the fiber.

A total of 2,675 units have been distributed worldwide, including 190 units in the US and 2,485 units outside the US in Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore.

Healthcare providers and facilities using these laser fibers should cease use of affected units immediately and contact Olympus for device replacement or further instructions. Users should review the recalled model and lot numbers, which cover all lot numbers for the specified models.

The recalled product

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)…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Surgical Laser Equipment
Hazard: thermal-incident
fire
burn-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

TFL-FBX365R-JA (Japan Only)
TFL-FBX200BS-JA (Japan Only)
TFL-FBX150R-JA (Japan Only)
TFL-FBX200R-JA (Japan Only)
TFL-FBX550R-JA (Japan Only)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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