# FDA recall Z-1071-2024

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-12-08.

## Product

Single Use Distal Cover 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

## Reason for recall

Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1071-2024
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-08
- **Report date:** 2024-02-21

- **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-1071-2024

## Citation

> AI Analytics. FDA recall Z-1071-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1071-2024. Source: US FDA. Licensed CC0.

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