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Use caution Medical device recall · FDA · Published May 12, 2026

Boston Scientific Orca Air/Water Valves Recall: Suction Button Sticking Risk

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.

🇺🇸 FDA recall #Z-2413-2026Medical deviceBoston Scientific ›
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Recalling firmBoston Scientific Corporation100 Boston Scientific Way · Marlborough, MA 01752-1234
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/49183-boston-scientific-orca-air-water-valves-recall-suction-button-sticking.

Source Summary by GovInfoNow · govinfonow.com/recall/49183-boston-scientific-orca-air-water-valves-recall-suction-button-sticking · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2413-2026

Cite this page

“Boston Scientific Orca Air/Water Valves Recall: Suction Button Sticking Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49183-boston-scientific-orca-air-water-valves-recall-suction-button-sticking. Based on FDA recall #Z-2413-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2413-2026%22&limit=1).

The FDA announced on May 12, 2026, that Boston Scientific Corporation is recalling Orca Single Use Air/Water and Suction Valves due to a suction button sticking hazard. The agency issued recall number Z-2413-2026 for the Class II device.

How to tell if you have it

  • Brand: Boston Scientific
  • Product: Orca Single Use Air/Water and Suction Valves
  • UPN: SUV-617-50
  • UPC: 00840253111012
  • Lot code: 38400303
  • Expiration date: January 20, 2029

The hazard

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. The record does not report specific incidents or injuries.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the August 24, 2026 Imager II Angiographic Catheters Recall for tip fracture risk and the August 6, 2026 LUX-Dx Cardiac Monitor System Recall for delayed AF burden alerts. Other recent recalls of similar products include the March 31, 2026 Erbe Medical ERBEFLO 2 Endoscopy Pump Tubing Recall and the January 29, 2026 Olympus Single Use Biopsy Valve Recall.

How to tell if you have this one

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.

  • Brand
    Boston Scientific
  • Product
    Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Valve Model

    Look for the Material Number (UPN) SUV-617-50 on the valve to confirm it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: May 12, 202612. FDA classified it Class II: Jun 11, 202623. Published in FDA’s Enforcement Report: Jun 17, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-2413-2026 (May 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2413-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA