Olympus Corporation of the Americas: Device Recall

Recall #Z-1715-2025 · 04/04/2025

Class II: Risk

Recall Details

Recall Number: Z-1715-2025
Classification: Class II
Product Type: Device
Recalling Firm: Olympus Corporation of the Americas
Status: Ongoing
Date Initiated: 04/04/2025
Location: Center Valley, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 189

Reason for Recall

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

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

Distribution Pattern

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

Other Recalls by Olympus Corporation of the Americas

Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.