Olympus Corporation of the Americas recalls Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy Syst

Recalling company

Olympus Corporation of the Americas

Product

Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G 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.

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Nov 14, 2025

Reported

Mar 11, 2026

Distribution

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

Status

Ongoing

Quantity

1684 units

Lot / codes

Model/Catalog Number: SPL-G; UDI: 00821925044203; Serial Numbers: All;

Company location

Center Valley, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-1479-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1479-2026 in the FDA Enforcement Report. Also see FDA recall press releases.