# FDA recall Z-0579-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2025-10-14.

## Product

Brand Name: EVIS EXERA III Duodenovideoscope  Product Name: Olympus TJF-Q190V  Model/Catalog Number: TJF-Q190V  Product Description: This instrument is intended to be used with an Olympus video system center, light source,  documentation equipment, monitor, EndoTherapy accessories (such as a biopsy forceps), and other  ancillary equipment for endoscopy and endoscopic surgery.

## Reason for recall

Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0579-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-14
- **Report date:** 2025-12-03

- **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-0579-2026

## Citation

> AI Analytics. FDA recall Z-0579-2026. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-0579-2026. Source: US FDA. Licensed CC0.

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