← FDA ENFORCEMENT
Z-2413-2026Class II

Boston Scientific Corporation

Recalling firm
Boston Scientific Corporation
Product type
Device
Status
Ongoing
Report date
2026-06-17
Distribution
US Nationwide distribution.
Firm state
MA
Product quantity
9750 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
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.

Product description

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.

Code / lot info

GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.