# FDA recall Z-0343-2024

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

## Product

Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagus, stomach, duodenum, and small intestine) by oral insertion or the lower digestive tract (including the anus, rectum, sigmoid colon, colon, ileocecal valve, and small intestine) by anal insertion. -  Model Number: SIF-Q180.

## 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-0343-2024
- **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-0343-2024

## Citation

> AI Analytics. FDA recall Z-0343-2024. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0343-2024. Source: US FDA. Licensed CC0.

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