FDAClass II · Medical device · Recalled June 17, 2026

Orca Single Use Air/Water and Suction Valves recall — Boston Scientific Corporation

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.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2413-2026
Brand: Boston Scientific
Classification: Class II
Units affected: 9750 units
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

Orca Single Use Air/Water and Suction Valves

Companies & origin

Recalling firm location: Marlborough, MA, United States
Firm address: 100 Boston Scientific Way, N/A, 01752-1234

Identifying details (verbatim from the notice)

Product codes / lots: GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
Distribution: US Nationwide distribution.
Firm notified the public via: Letter
FDA event ID: 98970
Recall initiated: May 12, 2026
FDA classified: June 11, 2026
FDA report date: June 17, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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