FDAMay 6, 2025device

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 flexibility to uretero...

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

00821925044111

Recall history

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

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