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-VC411Q-0720, Material REF: (1) N5391210, (2) N5391230, (3) N5777530, UDI-DI: (1) 04953170371110, (2) 04953170371110, (3) 04953170371110, 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 in endoscopic procedures for papillotomy. It allows for precise cutting during surgery, enhancing the effectiveness of the procedure.
Why This Is Dangerous
The device may deform if it did not undergo proper thermoforming, compromising its performance during use. This could lead to complications in procedures where precision is critical.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the device immediately to avoid potential complications during procedures.
Practical Guidance
How to identify if yours is affected
- Check the model number KD-VC411Q-0720 on the device packaging or label.
- Verify the device against the recall list provided by Olympus Corporation.
- Look for any notification letters from Olympus regarding the recall.
Where to find product info
Serial numbers and model numbers can typically be found on the device packaging or user manual.
What timeline to expect
Refund or replacement processing may take 4-6 weeks after contacting Olympus Corporation.
If the manufacturer is unresponsive
- Document all communications with Olympus Corporation.
- Reach out to the FDA for additional assistance.
- Consider filing a complaint if the issue persists.
How to prevent similar issues
- Always check for recall notices before using medical devices.
- Ensure devices have undergone proper quality checks before purchase.
- Consult healthcare professionals for device recommendations.
Documentation advice
Keep records of the purchase, recall notifications, and any correspondence with Olympus Corporation.
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Product Details
Model/Catalog Number: KD-VC411Q-0720. Distributed worldwide, including 3,038 units in the US and 6,970 units internationally. No price information available.
Key Facts
- Recall date: January 7, 2026
- Hazard level: High
- Total units recalled: 10,008
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Safety Guide
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