FDA DevicesClass II
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; ...
Published: June 17, 2026Recall ID: Z-2413-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 98970 |
| Address 1 | 100 Boston Scientific Way |
| Address 2 | N/A |
| Code info | GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029 |
| Postal code | 01752-1234 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 9750 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260512 |
| Initial firm notification | Letter |
| Center classification date | 20260611 |
Overview
- Recalling FirmBoston Scientific Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.