# FDA recall Z-1715-2025

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2025-04-04.

## Product

Brand Name: Powered Laser Surgical Instrument  Product Name: SOLTIVE Pro SuperPulsed Laser System  Model/Catalog Numbers: TFL-SLS, TFL-PLS  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

Preset treatment parameters are not consistently being used in accordance with the IFU.

## Distribution

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

## Key facts

- **Recall number:** Z-1715-2025
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-04
- **Report date:** 2025-05-07

- **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-1715-2025

## Citation

> AI Analytics. FDA recall Z-1715-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1715-2025. Source: US FDA. Licensed CC0.

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