Orca Single Use Air/Water and Suction Valves recall (Boston Scientific Corporation)
Medical deviceClass IIOngoing
Summary: Boston Scientific Corporation is recalling 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: 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.
What is being recalled
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.
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2413-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 12, 2026 |
| Reported | June 17, 2026 |
| Company | Boston Scientific Corporation |
| Company location | Marlborough, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 9750 units |
More recalls from Boston Scientific Corporation · all medical device recalls · recalls from May 2026