The Recall Desk
HighFDA (Devices)·Z-1694-2026·Announced 2026-04-08

[pending] Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser Sy

Pending LLM rewrite. Source: FDA_DEVICE Z-1694-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
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
Manufacturer
Olympus Corporation of the Americas
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Laser system: TFL-PLS
  • UDI: 00821925044111
  • Component Part: TFL-CPLU
  • UDI: 00821925044586
  • Serial #: MDUF220005
  • MDUF220005
  • MDUF220437
  • MDUF220446
  • MDUF190072
  • MDUF200324
  • MDUF210030
  • MDUF210204
  • MDUF210379
  • MDUF220001
  • MDUF220002
  • MDUF220003
  • MDUF220007
  • MDUF220008
  • MDUF220009
  • MDUF220010

Distribution

Distributed nationwide across the United States.

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