OER-ELITE Endoscope Reprocessor Connecting Tubes — Class II medical device recall Z-1904-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-04-29, distributed nationwide. Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
| Recall number | Z-1904-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2026-03-25 |
| Classified | 2026-04-22 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CN, HK, JP, KR, TW |
| Quantity | 373 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04953170404115 |
| Lot numbers | 09A, 0XA, 0YA, 0ZA, 11A, 25A, 26A, 27A, 28A, 45A, 46A, 47A, 48A, 49A, 4XA, 4YA, 51A |
| Model numbers | MAJ-2116 |
Product
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116.
Reason for recall
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
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-1904-2026. 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.