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-3025, Material REF: N1090210, UDI-DI: 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 instrument designed for use with an Olympus endoscope for papillotomy procedures. These devices are critical for minimally invasive surgeries.
Why This Is Dangerous
The lack of proper thermoforming in the manufacturing process can lead to deformation of the device, reducing its effectiveness and safety during use in medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may cause inconvenience for healthcare providers who rely on this device for procedures, potentially leading to delays in patient care.
Practical Guidance
How to identify if yours is affected
- Verify the model number on your device is KD-V411M-3025.
- Check the packaging for any recall notifications or letters from Olympus.
- Consult your healthcare provider for additional information on the recall.
Where to find product info
The model number and catalog number can typically be found on the device packaging or the device itself.
What timeline to expect
Expect a refund or replacement processing timeline of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all correspondence with Olympus regarding the recall.
- Follow up with customer service for updates on your request.
- Consider filing a complaint with the FDA if there is no response.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Look for devices with certifications indicating compliance with safety standards.
- Request information on the manufacturing process to understand safety measures.
Documentation advice
Keep a record of your purchase, any emails or letters from Olympus, and photographs of the device.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number: KD-V411M-3025. The product was distributed worldwide, including all U.S. states, with a total quantity of 1,025 units.
Key Facts
- Recall date: January 7, 2026
- High hazard level
- Notified via letter
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Safety Guide
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