Recall Z-0452-2026— Olympus Corporation of the Americas

Name: FDA recall Z-0452-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-08

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2025-10-08. It names one FDA 510(k) clearance: K171024. 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2025-10-08
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K171024 — ShockPulse-SE Lithotripsy SystemCybersonics, Inc.·cleared 2017-08-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.