FDAOctober 8, 2025device

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 reusabl...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00855279005023

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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