CLASS II ONGOING Device recall · Reported 11 Mar 2026 · FDA Enforcement Report

ShockPulse-SE Lithotripsy System Spl-sr ShockPulse-SE recalled

Olympus Corporation of the Americas is recalling ShockPulse-SE Lithotripsy System Spl-sr ShockPulse-SE Lithotripsy System - Reusable Probes, distributed nationwide in the US. The recall was initiated on 14 Nov 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Catalog Number: SPL-SR; UDI: 00821925043824; Serial Numbers: All;

Quantity recalled602 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1477-2026
FDA event ID: 98359
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Nov 2025
FDA classified: 27 Feb 2026
Reported: 11 Mar 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Nov 2025	Recall initiated by company
27 Feb 2026	Classified by FDA	+105 days
11 Mar 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

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.

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Model/Catalog Number: SPL-SR; UDI: 00821925043824; Serial Numbers: All;

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Bolivia, Chile, India, China, EU, Singapore, Australia, Korea, and Japan.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 98359

This product is part of a recall event; the main page for the event is ShockPulse-SE Lithotripsy System - Generator recalled.

Reported	Class	Recall	Company	Reason	Where
11 Mar 2026	CLASS II	ShockPulse-SE Lithotripsy System - Generator recalled	Olympus Corporation of the Americas	Other	Nationwide
11 Mar 2026	CLASS II	ShockPulse-SE Lithotripsy System Spl-s ShockPulse-SE recalled	Olympus Corporation of the Americas	Other	Nationwide

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