# FDA recall Z-1922-2025

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2025-05-06.

## 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), 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);    Product Description: SOLTIVE Laser Fibers are delivery devices that transmit laser energy from the laser console to the treatment site through the fiber tip. The laser connector secures the device to the laser.

## Reason for recall

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.

## Distribution

Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.

## Key facts

- **Recall number:** Z-1922-2025
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-06
- **Report date:** 2025-06-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1922-2025

## Citation

> AI Analytics. FDA recall Z-1922-2025. Retrieved 2026-07-30 from https://api.ai-analytics.org/recall/Z-1922-2025. Source: US FDA. Licensed CC0.

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