Boston Scientific Corporation: Endoscope Channel Accessory
Recall Summary Boston Scientific is recalling Orca Single Use Air/Water and Suction Valves (model SUV-617-50) used during gastrointestinal endoscope procedures nationwide because the suction button is sticking more often than expected. The valves were distributed across all U.S. states. This is a Class II recall, which means the device could cause serious health problems or failure, though it is not expected to cause death.
- Recalling firm
- 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
- 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
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-12
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f9dbb84d-bc52-4a6d-bd05-e041f151c45f