Olympus Corporation of the Americas recalls Brand Name: Lithotriptor

Recalling company

Olympus Corporation of the Americas

Product

Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T 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. Component: ShockPulse Lithotripsy System

Reason

The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Oct 8, 2025

Reported

Nov 19, 2025

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.

Status

Ongoing

Quantity

1528 units

Lot / codes

Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;

Company location

Center Valley, PA

Recall type

Voluntary: Firm initiated

Recall number

Z-0452-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0452-2026 in the FDA Enforcement Report. Also see FDA recall press releases.