OER-Elite Endoscope Reprocessor-for use in cleaning and high-level… — Class II medical device recall Z-0638-2022
Terminated recall by Olympus Corporation of the Americas, reported 2022-02-23, distributed nationwide. The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is i
| Recall number | Z-0638-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2021-12-13 |
| Classified | 2022-02-11 |
| Reported by FDA | 2022-02-23 |
| Terminated | 2023-12-26 |
| Distributed | Nationwide (US) |
| Quantity | 295 units |
| UPC / GTIN / UDI-DI | 04953170404047 |
| Serial numbers | 04953170404047 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0638-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.