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-VC412Q-0215, Material REF: (1) N5391410, (2) N5391430, (3) N5777730, UDI-DI: (1) 04953170371158, (2) 04953170371158, (3) 04953170371158, 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 designed for use in endoscopic procedures, specifically for papillotomy with high-frequency current. Healthcare providers use it during surgeries to access and treat the bile duct.
Why This Is Dangerous
The risk arises from devices that did not undergo thermoforming, which could cause deformation. This deformation affects the device's performance and reliability during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall poses a significant safety concern for healthcare providers and patients, necessitating immediate action to prevent potential complications.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device against the recalled model KD-VC412Q-0215.
- Verify if the device has a valid expiration date.
- Look for any signs of deformation or improper manufacturing.
Where to find product info
The model number and other identifiers can typically be found on the device packaging or labeling.
What timeline to expect
Expect a timeframe of 4-6 weeks for refund processing or replacement.
If the manufacturer is unresponsive
- Contact the manufacturer directly for follow-up.
- Document all correspondence related to the recall and keep records.
How to prevent similar issues
- Always verify the product's manufacturing details before use.
- Look for safety certifications on medical devices before purchasing.
Documentation advice
Keep a record of your purchase, including receipts and correspondence with the manufacturer.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC412Q-0215. It was distributed worldwide, including 413 units in the US and 1,505 units internationally. The recall affects all lots with a valid expiration date.
Key Facts
- Recalled product: Single Use 3-Lumen Sphincterotome V
- Model/Catalog Number: KD-VC412Q-0215
- Total units recalled: 1,918
- Risk of device deformation
- Immediate stop-use instruction issued
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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