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-V411M-0720, Material REF: (1) N1089610, (2) N5411330, UDI-DI: (1) 04953170184017, (2) 04953170380570, 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 medical procedures such as papillotomy, which involves cutting tissue using high-frequency current. Healthcare providers rely on this device for precise and safe surgical interventions.
Why This Is Dangerous
Improper thermoforming of the sphincterotome can lead to deformation, which may compromise its effectiveness during critical medical procedures. This poses a high risk for patients requiring such interventions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients directly, as the malfunctioning device could jeopardize patient safety during procedures. Immediate action is necessary to prevent any potential harm.
Practical Guidance
How to identify if yours is affected
- Verify the model number KD-V411M-0720 on your sphincterotome packaging.
- Check the expiration date to ensure it's valid before the recall date.
- Contact your healthcare provider to confirm if your device is affected.
Where to find product info
Look for the model number and expiration date on the device packaging or product label.
What timeline to expect
Expect processing for refunds or returns to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Reach out to Olympus customer service again.
- Document your attempts to contact the company and escalate your request if necessary.
- Consider filing a complaint with the appropriate regulatory agency.
How to prevent similar issues
- Always check for current recalls or safety notices before using medical devices.
- Look for safety certifications and compliance with medical standards when purchasing devices.
- Consult with healthcare providers about the latest safety information regarding medical products.
Documentation advice
Keep all correspondence regarding the recall, receipts of purchase, and any documentation related to the device usage for your records.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, model number KD-V411M-0720. It was distributed worldwide, including in 9,707 units in the U.S. The devices were sold at multiple retailers and have a classification of Class II.
Key Facts
- Recall date: January 7, 2026
- Distribution: Worldwide, including all U.S. states
- Total units recalled: 65,117
- Device classification: Class II
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