FDA Medical devices recall ·
ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE… recall
- Recall number
- Z-1477-2026
- Date
- (initiated November 14, 2025)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 602 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Brand 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.
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: SPL-SR; UDI: 00821925043824; Serial Numbers: All;
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1477-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.