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

Recall date

April 4, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1715-2025

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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