# FDA recall Z-0334-2024

> **Aizu Olympus Co., Ltd.** · Class II · device recall initiated 2023-09-25.

## Product

Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).  Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160.  510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.

## Reason for recall

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-0334-2024
- **Recalling firm:** Aizu Olympus Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-25
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aizuwakamatsu, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0334-2024

## Citation

> AI Analytics. FDA recall Z-0334-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0334-2024. Source: US FDA. Licensed CC0.

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