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
- Single Use 3-Lumen Sphincterotome
- Model numbers
- Model/Catalog Number: KD-VC411Q-0320, Material REF: (1) N5391030, (2) N5391010, (3) N5777330, UDI-DI: (1) 04953170466403, (2) 04953170466403, (3) 04953170466403, 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 during endoscopic procedures for papillotomy. It allows for precise cutting and is essential in certain gastrointestinal treatments.
Why This Is Dangerous
The device’s performance can be compromised if it deforms due to improper thermoforming, potentially leading to ineffective treatment during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a significant safety concern for patients requiring endoscopic procedures, necessitating immediate action from healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging: KD-VC411Q-0320.
- Verify if the device has undergone thermoforming by contacting the manufacturer.
- Look for any visible deformities before use.
Where to find product info
The model number and other identifiers can usually be found on the device packaging or the product's instruction manual.
What timeline to expect
Expect refunds or replacements to be processed within 4-6 weeks.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Contact the FDA if the company does not respond in a timely manner.
- Consider consulting a healthcare lawyer for further guidance.
How to prevent similar issues
- Always check for recalls before using any medical device.
- Request information from manufacturers regarding device safety and performance history.
- Consult with healthcare professionals regarding the use of recalled devices.
Documentation advice
Keep records of any communications with the manufacturer, including emails and letters. Document the product details, including model number and purchase date.
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Product Details
Model/Catalog Number: KD-VC411Q-0320. Distributed worldwide including all U.S. states. Quantity recalled: 5,946 units.
Key Facts
- Recalled product: Single Use 3-Lumen Sphincterotome V
- Model: KD-VC411Q-0320
- Total units recalled: 5,946
- Hazard: Potential deformation and performance loss
- Immediate action required: Stop using the device
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Safety Guide
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