# FDA recall Z-1610-2026

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2026-02-12.

## Product

Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.

## Reason for recall

The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1610-2026
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-12
- **Report date:** 2026-04-01

- **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-1610-2026

## Citation

> AI Analytics. FDA recall Z-1610-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1610-2026. Source: US FDA. Licensed CC0.

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