Recall Z-0452-2026 ยท FEO Lithotriptor, Ultrasonic
Olympus Corporation of the Americas
Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T 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-freq
| Date | Nov 7, 2025 (initiated Oct 8, 2025) |
| Status | Open, Classified |
| Reason | The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use. |
| Root cause | Device Design |
| Action | On October 8, 2025 URGENT: MEDICAL DEVICE ADVISORY NOTICE letters were sent to customers. Actions to be taken: Ensure you read the content of the notice. Ensure that all personnel are aware and knowledgeable on the content of the notice. You may continue to use the device according to 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 your customers, and forward them this notification. Olympus requests that you acknowledge receipt of this |
| Quantity | 1528 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171024 | ShockPulse-SE Lithotripsy System Cybersonics, Inc., Aug 21, 2017 |