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Boston Scientific Corporation: 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 t

Medical DevicesSource: FDA (device) · Date: 2026-06-17

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Boston Scientific Corporation
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.
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution.
Recall initiated
2026-05-12
Code info
GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
Product quantity
9750 units
Voluntary mandated
Voluntary: Firm initiated
City
Marlborough
State
MA
Country
United States
Event id
98970
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