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Recall Observatory FDA recall evidence

Device 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.

Z-2413-2026

May 12, 2026

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 98970
Status
Ongoing
Classification
Class II
Quantity
9750 units
Official record key
device-enforcement:Z-2413-2026

Official wording

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.

Code information: GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.