Z-0452-2026Class II

Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number...

Name: Z-0452-2026 Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number...
Creator: Olympus Corporation of the Americas
Published: 2025-10-08
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2025-10-08 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Product Description: The ShockPulse... on 2025-10-08. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0452-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-08
Posted: 2025-11-07
Recalling firm: OLYMPUS Corporation of the Americas
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 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. Component: ShockPulse Lithotripsy System
Product code: FEO Lithotriptor, Ultrasonic
Reason for recall: 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 tag: design
FDA 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 letter with the provided reply form.
Quantity in commerce: 1528 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.
Product codes and lots: Model/Catalog Number: SPL-T; UDI-PI: 00855279005023; All serial numbers;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0452-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0452-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-07

Product code FEO

K171024Class IIShockPulse-SE Lithotripsy SystemCybersonics, Inc. / cleared 2017-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)