WhichRecall
Class IIReported 2026-03-11

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.

Recalled by Olympus Corporation of the Americas

Reason for Recall

Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer

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Damage to the transducer plug and/or generator receptacle may cause these issues.

Recall Number
Z-1478-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-14
Reported
2026-03-11
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
Code Info
Model/Catalog Number: SPL-S; UDI: 00821925044197; Serial Numbers: All;
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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