# FDA recall Z-0638-2022

> **Olympus Corporation of the Americas** · Class II · device recall initiated 2021-12-13.

## Product

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories

## Reason for recall

The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed  instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the  alcohol cycle, resulting in a ineffective endoscope  reprocessing and patient exposure to residual detergent

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0638-2022
- **Recalling firm:** Olympus Corporation of the Americas
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-13
- **Report date:** 2022-02-23
- **Termination date:** 2023-12-26

- **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-0638-2022

## Citation

> AI Analytics. FDA recall Z-0638-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0638-2022. Source: US FDA. Licensed CC0.

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