# FDA recall Z-2197-2020

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2020-04-23.

## Product

OLYMPUS ShockPulse-SE Lithotripsy System,  Model SPL-T Transducer

## Reason for recall

A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.

## Distribution

Distribution US nationwide to states of: Texas, Ohio, New Mexico, California, Oklahoma, Michigan, Connecticut, North Carolina, Nebraska, and Pennsylvania; and Canada.

## Key facts

- **Recall number:** Z-2197-2020
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-23
- **Report date:** 2020-06-10
- **Termination date:** 2024-10-09

- **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-2197-2020

## Citation

> AI Analytics. FDA recall Z-2197-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2197-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*