FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: 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.
- Recall number
- Z-2413-2026
- 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.
- Status
- Open, Classified
- Initiated
- 2026-05-12
- Posted
- 2026-06-11
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 9750 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
- 510(k) numbers
- ["K252910"]
- PMA numbers
- not on file
- Product code
- ODC
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28