High FDA (Devices)·Z-1922-2025·Announced 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.

What this means for you

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 recall for a risk-of-harm medical device (thermal incidents including fire/burning hazard) where no reported injuries or deaths are stated in the source. Per the rubric, risk-of-harm products where injury has not yet been reported score at 3 (High).

Plain-English summary

Olympus Corporation of the Americas is recalling Soltive SuperPulsed Laser Fibers, single-use surgical devices that deliver laser energy from a laser console to treatment sites. The fibers are available in multiple model numbers including TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, and TFL-FBX940S, with additional Japan-only variants.

The recall addresses a potential for thermal incidents including unexpected smoke, sparks, burning, or unsteady flames during clinical use. Fiber fracturing is the cause of or contributes to these thermal incidents.

The recalled products have been distributed worldwide, including throughout the United States and in Australia, Canada, Chile, Germany, Hong Kong, Japan, and Singapore. A total of 551,154 units have been affected. Healthcare providers and facilities currently in possession of these devices should contact Olympus Corporation of the Americas for instructions on safe handling, discontinuation of use, or replacement of the affected products.

The recalled product

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

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 (13)

TFL-FBX200BS UDI: 00821925043985
TFL-FBX150S UDI: 00821925043886
TFL-FBX200S UDI: 00821925043947
TFL-FBX365S UDI: 00821925044005
TFL-FBX550S UDI: 00821925044043
TFL-FBX940S UDI: 00821925044081
TFL-FBX150BS-JA (Japan Only)
TFL-FBX550S-JA (Japan Only)
TFL-FBX940S-JA (Japan Only)
TFL-FBX200BS-JA (Japan Only)
TFL-FBX150S-JA (Japan Only)
TFL-FBX200S-JA (Japan Only)
TFL-FBX365S-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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Same hazard · fire