Olympus Corporation Of The Americas recalls Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotr…

Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.

Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.

On or about December 18, 2025 URGENT: MEDICAL DEVICE CORRECTION - UPDATE letters were sent to customers. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the new Supplemental Guidance. Add a copy of this letter with the Supplemental Guidance to your existing Instruction for Use. You may continue to use the device according to this letter and the instruction for use, which cautions users to ensure that a back-up transducer and probe are sterilized and available prior to beginning a procedure. If you have further distributed this product, identify and forward this notification to them.

• FDA enforcement recordOfficial FDA database entry for Z-1478-2026
• FDA 510(k) clearance · K171024The device's official FDA premarket clearance record
• FDA device classification · FEOOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.4480The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Olympus Corporation of the AmericasSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.