Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog… — Class II medical device recall Z-1295-2026
Ongoing recall by Olympus Corporation of the Americas, reported 2026-02-11, distributed nationwide. Devices which did not undergo thermoforming could deform and lose performance.
| Recall number | Z-1295-2026 |
|---|---|
| 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 | 2026-01-07 |
| Classified | 2026-02-05 |
| Reported by FDA | 2026-02-11 |
| Distributed | Nationwide (US) |
| Quantity | 650 units |
| Model numbers | KD-V411M-3020, N1090110 |
Product
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason for recall
Devices which did not undergo thermoforming could deform and lose performance.
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-1295-2026. 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.