Orca Single Use Air/Water and Suction Valves — Class II medical device recall Z-2413-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-06-17, distributed nationwide. Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Val
| Recall number | Z-2413-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2026-05-12 |
| Classified | 2026-06-11 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 9,750 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00840253111012 |
| Lot numbers | 38400303 |
| Expiration dates | 2029-01-20 |
Product
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.
Reason for recall
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
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-2413-2026. 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.