FDANovember 14, 2025device

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 tran...

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

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

00821925044203

Recall history

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

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