—#218451

Product

Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR 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.

FDA product code: FEO — Lithotriptor, Ultrasonic
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K171024
Affected lot / code info: Model/Catalog Number: SPL-SR; UDI: 00821925043824; Serial Numbers: All;

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.

Timeline

Recall initiated: 2025-11-14
Posted by FDA: 2026-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218451. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.