# FDA recall Z-2029-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-04-18.

## Product

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

## Reason for recall

The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.

## Distribution

US Nationwide distribution in the state of NY.

## Key facts

- **Recall number:** Z-2029-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-18
- **Report date:** 2024-06-12

- **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-2029-2024

## Citation

> AI Analytics. FDA recall Z-2029-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2029-2024. Source: US FDA. Licensed CC0.

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