Medical Device Recall: 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
Olympus Corporation of the Americas · April 4, 2025
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
Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.
States Affected
NATIONWIDE
Quantity Affected
189
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1715-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.