Quick Facts at a Glance
- Recall Date
- May 12, 2026
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Boston Scientific
- Model numbers
- GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 12, 2026
Reported by FDA DEVICE
June 17, 2026
RecallRadar source check
June 23, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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Full Description
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.. Reason: 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.. Classification: Class II. Quantity: 9750 units. Distribution: US Nationwide distribution.
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Safety Guide
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