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Olympus SOLTIVE Premium Laser System
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MEDICAL DEVICE RECALLMODERATE

Olympus SOLTIVE Premium Laser System

Olympus is recalling the SOLTIVE Premium Laser System (TFL-PLS) due to a power supply defect that may cause system failure or smoke.

What to do

Stop using the affected laser system immediately and contact Olympus for service or repair instructions.

Posted
Updated
Recall No.
Z-1694-2026
Agency
Firm
Olympus Corporation of the Americas
Recall ID
98422
Status
ONGOING

Why it was recalled

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.

How to identify it

UPC 00821925044111 00821925044586

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System

Where it was sold

Distributed in US.

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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification