Boston Scientific Corporation recalls Orca Single Use Air/Water and Suction Valves
- Recalling company
- Boston Scientific Corporation
- 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
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- May 12, 2026
- Reported
- Jun 17, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 9750 units
- Lot / codes
- GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
- Company location
- Marlborough, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2413-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2413-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.