FDA recall, , Moderate risk
Boston Scientific Orca Single Use Air/Water and Suction Valves
Orca Single Use Air/Water and Suction Valves have a suction button that can stick.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation, of Marlborough, Massachusetts, is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50, due to a higher than anticipated occurrence of the suction button sticking.
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. The removal began on May 12, 2026, and was added to the FDA's Enforcement Report on June 11, 2026.
The device was distributed nationwide in the United States. The removal involves 9750 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve
- UDI-DI
- 00840253111012
- 38400303
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Boston Scientific CorporationMarlborough, Massachusetts
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98970
- Recall number
- Z-2413-2026
- Quantity recalled
- 9750 units
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
