# FDA recall Z-0905-2025

> **Olympus Corporation of the Americas** · Class I · device recall initiated 2024-12-18.

## Product

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891.        This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.

## Reason for recall

Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-0905-2025
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-18
- **Report date:** 2025-01-22

- **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-0905-2025

## Citation

> AI Analytics. FDA recall Z-0905-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0905-2025. Source: US FDA. Licensed CC0.

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