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.
FDA Recall Z-2413-2026 · Posted 2026-06-11
Advertisement
Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeODC
Date Initiated2026-05-12
Product Quantity9750 units
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement