Official recall notice
FDA DeviceClass IINotable
FDA Recall: Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water V
- Recall date
- 2026-06-17
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Recommended action
What to do
9750 units
Product description
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.