Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to
FDA device recall Z-2413-2026 · posted 2026-06-11 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- ODC
- Quantity affected
- 9750 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2026-05-12
- Date posted
- 2026-06-11
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Orca Air/Water and Suction Valves (K252910) | Boston Scientific | 2025-10-09 |