# FDA recall Z-0418-2024

> **Aizu Olympus Co., Ltd.** · Class II · device recall initiated 2023-10-16.

## Product

PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE

## Reason for recall

Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.

## Distribution

Domestic distribution to FL, KY, MA, NJ, NY, and PA

## Key facts

- **Recall number:** Z-0418-2024
- **Recalling firm:** Aizu Olympus Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-16
- **Report date:** 2023-12-06

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0418-2024

## Citation

> AI Analytics. FDA recall Z-0418-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0418-2024. Source: US FDA. Licensed CC0.

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