# FDA recall Z-2676-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2026-06-05.

## Product

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid

## Reason for recall

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2676-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-06-05
- **Report date:** 2026-07-15

- **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-2676-2026

## Citation

> MORVS. FDA recall Z-2676-2026. Retrieved 2026-10-21 from https://api.morvs.ai/recall/Z-2676-2026. Source: US FDA. Licensed CC0.

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