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 V
- Model numbers
- Model/Catalog Number: KD-V431M-0720, Material REF: (1) N1090410, (2) N1090430, (3) N5411930, UDI-DI: (1) 04953170184178, (2) 04953170184178, (3) 04953170184178, 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 during papillotomy procedures in endoscopic surgeries. It allows healthcare providers to use high-frequency current for effective treatment.
Why This Is Dangerous
The devices may deform if they did not undergo proper thermoforming, which can compromise their performance in critical medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers need to stop using the recalled devices immediately to avoid potential complications during medical procedures.
Practical Guidance
How to identify if yours is affected
- Check the model number KD-V431M-0720 on your device.
- Ensure that your device has a valid expiration date.
- Refer to the recall notification for additional identifiers.
Where to find product info
Look for the model number and expiration date on the packaging or labeling of the device.
What timeline to expect
Refund processing may take approximately 4-6 weeks after your request is submitted.
If the manufacturer is unresponsive
- Contact Olympus customer service directly for follow-up.
- Document all communication attempts and keep records.
How to prevent similar issues
- Always verify the manufacturing process of medical devices before use.
- Look for recent recalls or safety notifications from manufacturers.
- Consult with healthcare providers about device safety before procedures.
Documentation advice
Keep records of your purchase, including receipts and any correspondence related to the recall.
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Product Details
The affected product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V431M-0720. It has been distributed globally, including in 50 U.S. states. The recall includes 11,779 units in the U.S. and 18,710 units internationally.
Key Facts
- Recall date: January 7, 2026
- 11,779 units distributed in the U.S.
- 18,710 units distributed internationally
- Devices designed for use with Olympus endoscopes
- High risk due to potential deformation
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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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