Olympus Corporation of the Americas recalls Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers

Recalled May 7, 2025 · FDA recall Z-1715-2025 · Olympus Corporation of the Americas

Hazard

Preset treatment parameters are not consistently being used in accordance with the IFU. · FDA Class II

Units

189

Sold at

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

Description

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

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

Manufacturer(s)

Olympus Corporation of the Americas

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →