FDA recall, , Moderate risk
Olympus ShockPulse-SE Lithotripsy System with Generator
The Olympus ShockPulse-SE Lithotripsy System has a mis-wired component that can cause noise and delay treatment.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, located in Center Valley, Pennsylvania, began a recall on January 8, 2026, of the Olympus ShockPulse-SE Lithotripsy System with Generator, a device used for intracorporeal fragmentation of stones in the urinary tract.
The recall was added to the FDA's Enforcement Report and classified on March 5, 2026, and in the FDA's weekly enforcement report on March 11, 2026. The reason is a mis-wired component that can result in additional noise on the power supply output, which is not consistent with electromagnetic compatibility standards and may decrease overall reliability, leading to delay of treatment.
The recall covers 55 units, all outside the United States, with international distribution in Canada, Germany, Singapore, Australia, and India.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
ShockPulse-SE Lithotripsy System with Generator
- Model number
- SPL-G
ShockPulse-SE Lithotripsy System - Reuseable Probes
- Model number
- SPL-SR
- UDI-DI
- 00821925043824
- 00821925044203
Recall details
- Company began the recall
- Sold in
International distribution in the country of Canada, Germany, Singapore, Australia, and India.
- Company
- Olympus Corporation of the AmericasCenter Valley, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98360
- Recall number
- Z-1494-2026
- Quantity recalled
- 55 units (All OUS)
All recalls from Olympus Corporation of the Americas
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
