FDAMay 6, 2025device

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-JA (Japan Only), TFL...

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

00821925043893008219250439090082192504395400821925043961008219250440120082192504402900821925044050008219250440670082192504410400821925044098

Recall history

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

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