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-0730, Material REF: (1) N1089810, (2) N5411530, UDI-DI: (1) 04953170380594, (2) 04953170380594, 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 used in medical procedures involving high-frequency current for papillotomy. Healthcare providers purchase this device for its precision during surgeries.
Why This Is Dangerous
The lack of thermoforming during manufacturing can cause the device to warp or deform, leading to performance issues during critical medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using this device to avoid potential risks during medical treatments, which may lead to delays in necessary procedures.
Practical Guidance
How to identify if yours is affected
- Check the product packaging for the model number KD-V411M-0730.
- Verify the expiration date to see if the device is still valid.
- Look for any deformities or unusual shapes in the device.
Where to find product info
The model number and expiration date can typically be found on the product packaging or label attached to the device.
What timeline to expect
Refund processing typically takes 4-6 weeks after the return of the product.
If the manufacturer is unresponsive
- Contact Olympus again for further assistance.
- Reach out to the FDA if you do not receive a response.
How to prevent similar issues
- Always verify product recalls before use.
- Check for manufacturing defects upon receipt of medical devices.
- Consult with healthcare professionals about device safety.
Documentation advice
Keep a record of all correspondence related to the recall, including receipts and communication with the manufacturer.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-0730. It was sold worldwide, including states such as California, Texas, and Florida. The exact price of the device is not provided.
Key Facts
- Recalled product: Single Use 3-Lumen Sphincterotome V
- Model Number: KD-V411M-0730
- Total units recalled: 86,303
- Manufacturing issue: Lack of thermoforming
- High hazard level due to performance risks
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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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