FDAMay 6, 2025device

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), TFL-FBX940S-JA (...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925043923008219250439850082192504388600821925043947008219250440050082192504404300821925044081

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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