Orca Single Use Air/Water and Suction Valves, Material… recallZ-2413-2026 · Boston Scientific Corporation · initiated May 12, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Boston Scientific issued an Urgent Medical Device Removal - Immediate Action Required notice to its consignees on 5/12/2026 via FedEx. The notice explained the issue with the device, potential risk to the patient, and requested the following: Actions " Immediately stop further use or distribution and segregate affected product. " Complete and return the enclosed Reply Verification Tracking Form per the included instructions. " Return product to Boston Scientific in accordance with the enclosed instructions. " Share this communication with any healthcare professionals in your hospital that use the product and with any other organization to which these systems may have been transferred. For additional assistance or more information regarding this communication, please contact your local Boston Scientific representative.
Recall details
- Recall number
- Z-2413-2026
- Status
- Open, Classified
- Initiated by the company
- May 12, 2026
- Posted by the FDA
- Jun 11, 2026
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 9750 units
- Product code
- ODC
- FDA submissions
- K252910
- Distribution
- US Nationwide distribution.
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 information (models, lots, serial numbers)
GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Orca™ SUV-617Boston Scientific Corporation · Endoscope Channel Accessory1 recall64 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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