# FDA recall Z-0181-2025

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-08-21.

## Product

Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100

## Reason for recall

It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0181-2025
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-08-21
- **Report date:** 2024-10-30

- **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-0181-2025

## Citation

> AI Analytics. FDA recall Z-0181-2025. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-0181-2025. Source: US FDA. Licensed CC0.

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