FDA recall, , Moderate risk
Olympus ShockPulse-SE Lithotripsy System Reusable Probes, Single Use Probes and Generator
The ShockPulse-SE Lithotripsy System can remain in a blinking phase waiting to recognize the transducer due to damage to the plug or receptacle.
Summary by Recall Canary from the FDA notice
What happened
Olympus Corporation of the Americas, based in Center Valley, Pennsylvania, recalled the ShockPulse-SE Lithotripsy System because 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.
The recall began November 14, 2025, and was added to the FDA's Enforcement Report on February 27, 2026, with distribution nationwide and in Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
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?
3 products
Match the UDI-DI and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
ShockPulse-SE Lithotripsy System SPL-S ShockPulse-SE Lithotripsy System - Single Use Probes
- UDI-DI
- 00821925044197
- Model/Catalog number
- SPL-S
ShockPulse-SE Lithotripsy System - Generator
- UDI-DI
- 00821925044203
- Model/Catalog number
- SPL-G
ShockPulse-SE Lithotripsy System SPL-SR ShockPulse-SE Lithotripsy System - Reusable Probes
- UDI-DI
- 00821925043824
- Model/Catalog number
- SPL-SR
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
- 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
- 98359
- Recall numbers
- Z-1477-2026 to Z-1479-2026
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
