| Date Initiated by Firm | May 12, 2026 |
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| Date Posted | June 11, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2413-2026 |
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| Recall Event ID |
98970 |
| 510(K)Number | K252910 |
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| Product Classification |
Endoscope channel accessory - Product Code ODC
|
| 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. |
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| Code Information |
GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029 |
| FEI Number |
3005099803
|
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
|
| For Additional Information Contact | Renee Archie
508-683-4523 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Process control |
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| 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. |
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| Quantity in Commerce | 9750 units |
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| Distribution | US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = ODC
|
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