Olympus Single Use Distal Cover — Class II medical device recall Z-2676-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-07-15, distributed nationwide. Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous d
| Recall number | Z-2676-2026 |
|---|---|
| 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 | 2026-06-05 |
| Classified | 2026-07-07 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| Quantity | 988,700 units |
| UPC / GTIN / UDI-DI | 04953170441271 |
| Lot numbers | H2530 |
| Model numbers | MAJ-2315 |
Product
Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
Reason for recall
Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
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-2676-2026. 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.