Olympus Single Use Biopsy Valve — Class II medical device recall Z-1489-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-03-11, distributed nationwide. Potential for rubber fragment detachment during use.
| Recall number | Z-1489-2026 |
|---|---|
| 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 | 2026-01-29 |
| Classified | 2026-03-03 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material, device malfunction |
| UPC / GTIN / UDI-DI | 14953170154291 |
| Model numbers | MAJ-1218 |
Product
Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.
Reason for recall
Potential for rubber fragment detachment during use.
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-1489-2026. 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.