Boston Scientific recalls Orca Single Use Air/Water and Suction Valves (UPN SUV-617-50) due to suction button sticking during endoscopic procedures. Affected units have GTIN 00840253111012 and lot 38400303.
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.
Boston Scientific is recalling Orca Single Use Air/Water and Suction Valves with Material Number SUV-617-50 because the suction button may stick during endoscopic procedures. This could cause improper suction control, potentially leading to complications during medical procedures.
The suction button may stick during endoscopic procedures, causing improper suction control. This could lead to inadequate removal of fluids or tissues, potentially causing complications during the procedure.
Medical professionals using endoscopes during gastrointestinal procedures are most at risk. Patients undergoing these procedures may be affected if the valve malfunctions.
Check for the Material Number (UPN) SUV-617-50 on the valve. The product has GTIN 00840253111012 and was manufactured in lot 38400303, expiring January 20, 2029.
Look for the Material Number (UPN) SUV-617-50 on the valve to confirm it is affected.
Boston Scientific is recalling these valves due to a higher than anticipated occurrence of the suction button sticking during endoscopic procedures.
Check the Material Number (UPN) SUV-617-50 on the valve. If it matches, contact Boston Scientific for further instructions.
The recall record does not mention a specific fix or remedy.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2413-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2413-2026 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.