# FDA recall Z-1920-2025

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

## Product

Brand Name: Powered Laser Surgical Instrument  Product Name: SOLTIVE Pro SuperPulsed Laser System  Model/Catalog Number: TFL-SLS, TFL-SLS-JA (Japan only);  Product Description: SOLTIVE Laser Systems use technology to increase procedural efficiency and flexibility to ureteroscopy, PCNL, and potential soft tissue applications.  Component: No

## 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-1920-2025
- **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-1920-2025

## Citation

> AI Analytics. FDA recall Z-1920-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1920-2025. Source: US FDA. Licensed CC0.

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