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-0725, Material REF: (1) N1089710, (2) N5411430, UDI-DI: (1) 04953170380587, (2) 04953170380587, 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 endoscopic procedures, specifically for papillotomy with high-frequency current. Healthcare providers purchase this device to facilitate specific surgical interventions.
Why This Is Dangerous
The defect arises from the lack of proper thermoforming during manufacturing, which can result in deformation of the device. Such deformation may compromise the device's intended function, posing serious risks during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face immediate health risks due to the potential for device malfunction. The recall also emphasizes the importance of safety in medical device manufacturing.
Practical Guidance
How to identify if yours is affected
- Locate the model number KD-V411M-0725 on the device packaging.
- Verify if your device is part of the recall by checking with Olympus or your healthcare provider.
- Ensure the device has a valid expiration date before checking its status.
Where to find product info
The model number and expiration date can typically be found on the device packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement processing timeline of about 4-6 weeks after following the recall instructions.
If the manufacturer is unresponsive
- Contact Olympus customer service for further assistance.
- Document all communication attempts in case of delays.
How to prevent similar issues
- Always verify the manufacturing details of medical devices before purchase.
- Look for safety certifications and recall history in medical device documentation.
- Consult with healthcare professionals about device safety prior to use.
Documentation advice
Keep records of your device's model number, purchase documentation, and any correspondence with Olympus regarding the recall.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-0725. The recall includes 9,959 units distributed in the U.S. and 126,078 units internationally.
Key Facts
- Recall date: January 7, 2026
- High hazard level due to potential device deformation
- 9,959 units distributed in the U.S. and 126,078 units internationally
- Immediate stop-use directive for patients and healthcare providers
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Safety Guide
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