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Olympus SOLTIVE Laser System
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MEDICAL DEVICE RECALLMODERATE

Olympus SOLTIVE Laser System

Olympus recalls SOLTIVE laser systems (TFL-SLS, TFL-PLS) due to power supply defect that may cause inoperability and smoke.

What to do

If you have an affected SOLTIVE laser system, stop using it immediately and contact Olympus for repair or replacement. Do not attempt to open the console; the smoke or burning smell is contained and self-extinguishing.

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

Why it was recalled

Olympus is recalling the SOLTIVE Pro and SOLTIVE Premium SuperPulsed Laser Systems (models TFL-SLS and TFL-PLS) because a potential defect in the 24V power supply module may cause the system to become inoperable, and smoke or a burning smell may occur. The issue is contained within the internal laser console enclosure and is self-extinguishing.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

ProductRecall #UDI-DIModel/Catalog number
Olympus SOLTIVE Premium SuperPulsed Laser System SOLTIVE Premium Laser System TFL-PLSZ-1694-202600821925044111, 00821925044586TFL-PLS containing TFL-CPLU
Olympus SOLTIVE Pro SuperPulsed Laser System SOLTIVE Pro Laser System TFL-SLSZ-1695-202600821925044135, 00821925044593TFL-SLS containing TFL-CSLU

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

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Editorial summary by Recall Canary · summary updated 2026-08-25 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification