Boston Scientific Corporation recalls Orca Single Use Air/Water and Suction Valves

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.

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.

Boston Scientific issued an Urgent Medical Device Removal - Immediate Action Required notice to its consignees on 5/12/2026 via FedEx. The notice explained the issue with the device, potential risk to the patient, and requested the following: Actions " Immediately stop further use or distribution and segregate affected product. " Complete and return the enclosed Reply Verification Tracking Form per the included instructions. " Return product to Boston Scientific in accordance with the enclosed instructions. " Share this communication with any healthcare professionals in your hospital that use the product and with any other organization to which these systems may have been transferred. For additional assistance or more information regarding this communication, please contact your local Boston Scientific representative.

• FDA enforcement recordOfficial FDA database entry for Z-2413-2026
• FDA 510(k) clearance · K252910The device's official FDA premarket clearance record
• FDA device classification · ODCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 876.1500The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Boston Scientific CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.