Recall Z-2413-2026
Boston Scientific Corporation · initiated May 12, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2413-2026
- Initiated
- May 12, 2026
- Posted by FDA
- June 11, 2026
- Product code
- ODC – Endoscope Channel Accessory
- Quantity
- 9750 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA