Agency classClass IIOur severity:High FDA (Devices)·Z-1478-2026·Announced 2026-03-11

Olympus lithotripsy single use probes recalled over generator recognition failure

Olympus is recalling ShockPulse-SE Lithotripsy System single use probes after further instances of the generator remaining in a blinking phase waiting to recognize the transducer.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the system can fail to recognise its transducer and become unusable during a procedure, and no injuries are stated in the source.

Plain-English summary

Olympus Corporation of the Americas is recalling the ShockPulse-SE Lithotripsy System Single Use Probes, model SPL-S. The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. About 1,082 units were distributed worldwide, covering the United States nationwide and Canada, Mexico, Bolivia, Chile, India, China, the EU, Singapore, Australia, Korea and Japan. The FDA has classified this recall as Class II.

Ongoing investigations identified additional instances of the device generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug or generator receptacle may cause these issues.

All serial numbers are affected. The device carries UDI 00821925044197.

Facilities can identify affected probes by the model number and UDI above, and may contact Olympus Corporation of the Americas for further information.

The recalled product

Product: Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and…
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Lithotripsy
Hazard: device-malfunction
connector-damage
treatment-delay
Affected units: 1,082

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-S
UDI: 00821925044197
Serial Numbers: All

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Olympus Corporation of the Americas

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