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-0330, Material REF: (1) N5391130, (2) N5391110, (3) N5777430, UDI-DI: (1) 04953170371097, (2) 04953170371097, (3) 04953170371097, 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 and guidewire for papillotomy procedures. Healthcare providers use it to perform specific gastrointestinal interventions, relying on its precise functionality.
Why This Is Dangerous
If the sphincterotome does not undergo proper thermoforming, it may deform, affecting its ability to function as intended during medical procedures. This could lead to ineffective treatment or complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face potential risks during procedures if the device is used. Immediate action is necessary to ensure safety and compliance with the recall.
Practical Guidance
How to identify if yours is affected
- Locate the device model number KD-VC411Q-0330 on the packaging or device.
- Verify the device against the recall notice to see if it is affected.
- Check the expiration date to ensure it is within the valid range.
Where to find product info
The model number can typically be found on the device packaging or in the user manual.
What timeline to expect
Expect a refund or instructions for replacement within 4-6 weeks after contacting Olympus.
If the manufacturer is unresponsive
- Document all correspondence with Olympus regarding the recall.
- Reach out again to Olympus through different channels if no response is received.
- Consider filing a complaint with relevant health authorities if the issue persists.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Verify the manufacturing process and certifications of medical devices before purchase.
- Consult with healthcare providers about the safety of new medical devices before use.
Documentation advice
Keep all receipts, correspondence, and any records of complaints regarding the device for your records.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC411Q-0330. These devices were distributed worldwide, including 30 units in the US and 5,059 internationally. No price was mentioned.
Key Facts
- Recall date: January 7, 2026
- Reported date: February 11, 2026
- High hazard level
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Safety Guide
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