Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS… — Class II medical device recall Z-1613-2023
Ongoing recall by Olympus Corporation of the Americas, reported 2023-05-31, distributed nationwide. The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during
| Recall number | Z-1613-2023 |
|---|---|
| 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 | 2023-04-18 |
| Classified | 2023-05-19 |
| Reported by FDA | 2023-05-31 |
| Distributed | Nationwide (US) |
| Quantity | 309,278 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04953170403019 |
| Model numbers | MAJ-2315, N5786100 |
Product
Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
Reason for recall
The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.
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-1613-2023. 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.