# FDA recall Z-2447-2023

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2023-07-12.

## Product

The Air/Water Valve is provided/used with the following Endoscopes:  ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE:  GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130,  GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5

## Reason for recall

The air/water valve MAJ-1444 used with OER-Pro  and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2447-2023
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-12
- **Report date:** 2023-08-30

- **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-2447-2023

## Citation

> AI Analytics. FDA recall Z-2447-2023. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-2447-2023. Source: US FDA. Licensed CC0.

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