# FDA recall Z-0329-2024

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

## Product

Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve).  Model Numbers: CF-2T160I, CF-2T160L, CF-H170I, CF-H170L, CF-H180AI, CF-H180AL, CF-H180DI, CF-H180DL, CF-H190I, CF-H190L, CF-HQ190I, CF-HQ190L, CF-LV1I, CF-LV1L, CF-Q150I, CF-Q150L, CF-Q160S, CF-Q180AI, CF-Q180AL.  510(k) Numbers: K954451, K112680, K100584, K051645, K111756, K001241, K911278.

## 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-0329-2024
- **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-0329-2024

## Citation

> AI Analytics. FDA recall Z-0329-2024. Retrieved 2026-07-03 from https://api.ai-analytics.org/recall/Z-0329-2024. Source: US FDA. Licensed CC0.

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