FDA-Device2026-06-17Class IIPROCESSING DEFECT
Boston Scientific Orca Single Use Air/Water and Suction Valves recalled for suction button sticking
What this means
Boston Scientific is removing Orca Sterile Single Use Air/Water and Suction Valves from distribution because the suction button is sticking more often than expected. These valves are used during gastrointestinal endoscopic procedures to control air and water flow on endoscopes. No injuries have been reported.
- If you have Orca valves (Material Number SUV-617-50, Lot 38400303, Exp. January 20, 2029), stop using them and contact Boston Scientific.
- Do not use affected units in any endoscopic procedures.
- Return or quarantine the affected valves according to your facility's procedures.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
9750 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2413-2026More Boston Scientific recalls
- FDA-Device2026-09-09Boston Scientific LUX-Dx insertable cardiac monitor server software recalled for delayed AF alert notification
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor system recalled for delayed alert notifications
- FDA-Device2026-09-09Boston Scientific LUX-Dx cardiac monitor server software recalled for delayed alert notifications
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARADRIVE Steerable Sheath recalled for air embolism risk from valve damage
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