FDAJanuary 8, 2026device

Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatical...

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

The hazard

Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

0082192504382400821925044203

Recall history

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

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