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-V411M-1520, Material REF: (1) N5411630, (2) N1089910, UDI-DI: (1)04953170380600, (2) N/A, 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 in papillotomy procedures. Healthcare providers purchase it for its ability to facilitate specific endoscopic interventions.
Why This Is Dangerous
Improper thermoforming can cause the device to deform during use, potentially compromising its effectiveness in medical procedures. This can pose serious risks to patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must stop using the affected devices immediately, which could lead to delays in scheduled procedures and a need for alternative instruments.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device to see if it is KD-V411M-1520.
- Verify that your device has not undergone thermoforming as indicated in the recall notice.
- Look for any notifications from Olympus Corporation regarding this recall.
Where to find product info
The model number is typically located on the packaging or the device itself. Check any accompanying documentation as well.
What timeline to expect
Expect a refund or replacement processing time of 4-6 weeks.
If the manufacturer is unresponsive
- Contact Olympus customer service directly for updates.
- File a complaint with the FDA if the response is unsatisfactory.
How to prevent similar issues
- When purchasing medical devices, ensure they are from reputable manufacturers with a proven safety record.
- Request information on the manufacturing and quality assurance processes of medical instruments.
Documentation advice
Keep records of all correspondence regarding the recall, including emails and phone call notes. Document any usage of the device prior to recall notification.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The affected product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-1520. It was distributed worldwide, including across all U.S. states. The product is used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Key Facts
- Risk of deformation and performance loss
- Immediate stop-use action required
- No injuries reported
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.