# FDA recall Z-0452-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2025-10-08.

## 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

## 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.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, India, Taiwan, Germany, Australia, Singapore.

## Key facts

- **Recall number:** Z-0452-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-08
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Center Valley, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0452-2026

## Citation

> AI Analytics. FDA recall Z-0452-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0452-2026. Source: US FDA. Licensed CC0.

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