# FDA recall Z-1489-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2026-01-29.

## Product

Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box.    The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.

## Reason for recall

Potential for rubber fragment detachment during use.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1489-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-29
- **Report date:** 2026-03-11

- **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-1489-2026

## Citation

> AI Analytics. FDA recall Z-1489-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1489-2026. Source: US FDA. Licensed CC0.

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