The Recall Desk
HighFDA (Devices)·Z-1922-2025·Announced 2025-06-18

[pending] Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Sing

Pending LLM rewrite. Source: FDA_DEVICE Z-1922-2025.

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

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.

The recalled product

Product
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed Laser Fibers - Single Use Model/Catalog Numbers: TFL-FBX150BS, TFL-FBX200BS, TFL-FBX150S, TFL-FBX200S, TFL-FBX365S, TFL-FBX550S, TLF-FBX940S, TFL-FBX150BS-JA (Japan Only), TFL-FBX550S-JA (Japan Only
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 (13)

  • TFL-FBX200BS UDI: 00821925043985
  • TFL-FBX150S UDI: 00821925043886
  • TFL-FBX200S UDI: 00821925043947
  • TFL-FBX365S UDI: 00821925044005
  • TFL-FBX550S UDI: 00821925044043
  • TFL-FBX940S UDI: 00821925044081
  • TFL-FBX150BS-JA (Japan Only)
  • TFL-FBX550S-JA (Japan Only)
  • TFL-FBX940S-JA (Japan Only)
  • TFL-FBX200BS-JA (Japan Only)
  • TFL-FBX150S-JA (Japan Only)
  • TFL-FBX200S-JA (Japan Only)
  • TFL-FBX365S-JA (Japan Only)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category