FDAFebruary 27, 2026device

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with mod...

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

The hazard

Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

0082192504411100821925044586

Recall history

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

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