Brand Name: ShockPulse-SE Lithotripsy System SPL-S recall
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S…
Why was Brand Name: ShockPulse-SE Lithotripsy System SPL-S 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 I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Catalog Number: SPL-S; UDI: 00821925044197; Serial Numbers: All;
- Product
- Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S…
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1082 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.
- Recall date
- March 11, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)