# FDA recall Z-0498-2025

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2024-09-18.

## Product

Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190  Product Name: Olympus GIF-1TH190  Model/Catalog Number: GIF-1TH190  Software Version: N/A  Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.

## Reason for recall

To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.

## Distribution

Domestic: US Nationwide Distribution.

## Key facts

- **Recall number:** Z-0498-2025
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-18
- **Report date:** 2024-11-27

- **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-0498-2025

## Citation

> AI Analytics. FDA recall Z-0498-2025. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-0498-2025. Source: US FDA. Licensed CC0.

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