# FDA recall Z-0697-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-11-06.

## Product

Olympus ENDOEYE HD II Rigid Videoscope  Catalog Numbers: WA50040A, WA50042A  -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

## Reason for recall

Reports of a pink or green coloration of the image. If the issue is encountered during a procedure, device exchange could potentially result in prolonged surgery; potential visual impacts mucosal injury or bleeding may occur.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0697-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-06
- **Report date:** 2024-01-17

- **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-0697-2024

## Citation

> AI Analytics. FDA recall Z-0697-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0697-2024. Source: US FDA. Licensed CC0.

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