Recall Z-1715-2025— Olympus Corporation of the Americas

Name: FDA recall Z-1715-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-04

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-04-04. It names one FDA 510(k) clearance: K242191. 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: Preset treatment parameters are not consistently being used in accordance with the IFU..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2025-04-04
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K242191 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America·cleared 2024-08-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.