FDAHealthMay 12, 2026
Boston Scientific Corporation — 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
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 12, 2026
US Nationwide distribution.
What's affected?
- 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.
- Lot code
- 38400303
Additional details
GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 9750 units.
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