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-0330, Material REF: (1) N1089530, (2) N1089510, (3) N5411230, UDI-DI: (1) 04953170380563, (2) 04953170380563, (3) 04953170380563, 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 used with endoscopes for papillotomy procedures. It is designed to utilize high-frequency current for surgical interventions.
Why This Is Dangerous
The hazard arises when devices that did not undergo thermoforming deform, leading to potential performance issues during critical medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should stop using the recalled device immediately to avoid risks associated with potential deformation and compromised performance.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device.
- Confirm if it is KD-V411M-0330 to determine if it is affected by the recall.
- Check for any communication from the manufacturer regarding the recall.
Where to find product info
The model number can typically be found on the device packaging or the device itself.
What timeline to expect
Expect a refund or replacement to be processed within 4-6 weeks after the return of the product.
If the manufacturer is unresponsive
- Document all communication attempts with Olympus.
- Contact the FDA if there is no response after multiple attempts.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Use only devices that have been verified for safety and quality.
Documentation advice
Keep records of your communications with the manufacturer and any receipts or purchase confirmations.
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Product Details
The recall involves the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-0330. The recalled units are distributed worldwide, including 36 in the U.S. The devices were used with Olympus endoscopes and guidewires for papillotomy.
Key Facts
- Deformation risk affects performance
- Used with Olympus endoscopes
- Immediate stop-use recommendation
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Safety Guide
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