FDA recall Z-2413-2026

Boston Scientific Corporation · Class II · 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.

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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2026-05-12
Report date
2026-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Marlborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2413-2026