Z-2413-2026 Class II Ongoing
FDA device recall Z-2413-2026 was initiated by Boston Scientific Corporation on May 12, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 9750 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- May 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9750 units
Product Description
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.
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029