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-3030, Material REF: (1) N5411830, (2) N1090310, UDI-DI: (1)04953170184154, (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 instrument designed for use in endoscopic procedures, specifically for papillotomy using high-frequency current. It is often used in hospitals and medical facilities during surgical procedures.
Why This Is Dangerous
The risk arises from devices that did not undergo proper thermoforming, which may lead to deformation. Deformed devices can compromise the safety and effectiveness of medical procedures, posing significant risks to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers using this device should stop immediately to avoid potential complications during medical procedures. The recall does not currently indicate any injuries, but the high-risk classification highlights the urgency for action.
Practical Guidance
How to identify if yours is affected
- Check the product label for the model number KD-V411M-3030.
- Verify the device's expiration date to ensure it is valid.
- Consult the recall notification letter for specific instructions.
Where to find product info
The model number and expiration date can typically be found on the packaging or the device itself.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Reach out to regulatory bodies if the issue remains unresolved.
How to prevent similar issues
- When purchasing medical devices, verify they have undergone proper quality checks.
- Check for FDA approval and recall history before use.
- Consult healthcare providers for safe alternatives.
Documentation advice
Keep all receipts, correspondence regarding the recall, and photos of the product as records.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number: KD-V411M-3030. The device is designed for use with an Olympus endoscope and guidewire for papillotomy using high-frequency current. It was distributed worldwide, including various states across the U.S.
Key Facts
- Recall date: January 7, 2026
- Classification: Class II
- Hazard: Deformation risk
- Distribution: Worldwide, including all U.S. states
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Safety Guide
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