Quick Facts at a Glance
- Recall Date
- January 7, 2026
- Hazard Level
- HIGH
- Brand
- Olympus Corporation of the Americas
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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
- Olympus Corporation of the Americas
- Product type
- Sphincterotome
- Model numbers
- Model/Catalog Number: KD-V411M-1530, Material REF: (1) N5411730, (2) N1090010, UDI-DI: (1)04953170380617, (2)N/A, All Lots with a valid expiration date
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 7, 2026
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Devices which did not undergo thermoforming could deform and lose performance.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
About This Product
The Single Use 3-Lumen Sphincterotome V is a medical device designed for use in endoscopic procedures to facilitate papillotomy. Healthcare professionals purchase it for its ability to precisely navigate and perform procedures involving the bile ducts.
Why This Is Dangerous
The devices in question did not undergo proper thermoforming, which can cause them to lose shape and functionality during medical procedures. This deformation can lead to serious complications if not identified prior to use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may face delays in medical procedures requiring this device, and healthcare providers must find alternative methods, impacting patient care and operational efficiency.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device: KD-V411M-1530.
- Verify the expiration date to ensure it is within the valid range.
- Consult purchase records to confirm the acquisition date.
Where to find product info
The model number can typically be found on the device packaging or the device itself, usually near the manufacturer's label.
What timeline to expect
Expect refund processing to take 4-6 weeks once the return request is initiated.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Contact the FDA or a healthcare regulatory body for guidance.
- Consider filing a complaint if no response is received.
How to prevent similar issues
- Always verify the latest safety alerts for medical devices.
- Use only devices from reputable manufacturers with established safety records.
- Ensure devices are inspected and tested before use.
Documentation advice
Keep receipts, correspondence with the manufacturer, and photographs of the recalled device for your records.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-1530. It was designed for use with an Olympus endoscope and guidewire for papillotomy. The devices were distributed widely across the U.S. and internationally.
Key Facts
- Recall date: January 7, 2026
- Class II medical device
- Risk of deformation due to improper thermoforming
- Immediate action required by users
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Safety Guide
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