Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog
Pending LLM rewrite. Source: FDA_DEVICE Z-0452-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- 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 tra
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model/Catalog Number: SPL-T
- UDI-PI: 00855279005023
- All serial numbers
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereABIOMED Introducer Kit 23 Fr heart pump accessory leakage risk
FDA (Devices) · 2026-07-22
- HighGE Medical Optima XR200/220/240amx Mobile Radiographic Systems Recall
FDA (Devices) · 2026-07-22
- SevereABIOMED Impella RP Flex heart pump introducer sheath leakage risk
FDA (Devices) · 2026-07-22
- ModeratePapablic Replacement Brush Heads Recalled for Potential Breakage
FDA (Devices) · 2026-07-22
- HighRapid Refill Continuous Injection System Recalled for Syringe Loosening Risk
FDA (Devices) · 2026-07-22