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U.S. Department of Health and Human Services

Class 2 Device Recall ShockPulseSE Lithotripsy System SPLSR

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 Class 2 Device Recall ShockPulseSE Lithotripsy System SPLSRsee related information
Date Initiated by FirmNovember 14, 2025
Date PostedFebruary 27, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1477-2026
Recall Event ID 98359
510(K)NumberK171024 
Product Classification Lithotriptor, ultrasonic - Product Code FEO
ProductBrand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Code Information Model/Catalog Number: SPL-SR; UDI: 00821925043824; Serial Numbers: All;
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Device Design
ActionOn or about December 18, 2025 URGENT: MEDICAL DEVICE CORRECTION - UPDATE letters were sent to customers. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, including the new Supplemental Guidance. Add a copy of this letter with the Supplemental Guidance to your existing Instruction for Use. You may continue to use the device according to this letter and the instruction for use, which cautions users to ensure that a back-up transducer and probe are sterilized and available prior to beginning a procedure. If you have further distributed this product, identify and forward this notification to them.
Quantity in Commerce602 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FEO
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