Z-2413-2026Class II

Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is...

Name: Z-2413-2026 Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is...
Creator: Boston Scientific Corporation
Published: 2026-05-12
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-05-12 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of 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... on 2026-05-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2413-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-12
Posted: 2026-06-11
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.
Product code: ODC Endoscope Channel Accessory
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 9750 units
Distribution: US Nationwide distribution.
Product codes and lots: GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2413-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2413-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-11

Product code ODC

K252910Class IIOrca Air/Water and Suction ValvesBoston Scientific / cleared 2025-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)