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-VC411Q-0725, Material REF: N5424710, UDI-DI: 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 with Olympus endoscopes for performing papillotomy. It is typically used in surgical procedures to facilitate access to the bile duct.
Why This Is Dangerous
Devices that did not undergo proper thermoforming may deform, leading to performance issues during medical procedures, which can jeopardize patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires immediate attention from healthcare providers and may lead to temporary disruptions in medical procedures.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device, which is KD-VC411Q-0725.
- Check for any notification letters from Olympus regarding the recall.
- Stop using the device if it matches the recalled model.
Where to find product info
The model number can usually be found on the packaging or directly on the device itself.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements after following the recall instructions.
If the manufacturer is unresponsive
- Contact Olympus Corporation customer service directly.
- Document all communications and follow up if necessary.
How to prevent similar issues
- Always verify the safety of medical devices before use.
- Check for any recalls or safety notices prior to procedures.
- Ensure devices are from reputable manufacturers.
Documentation advice
Keep a record of the device's model number, purchase date, and any correspondence with the manufacturer.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC411Q-0725. It was distributed worldwide, including all states in the U.S. The devices were designed for use with Olympus endoscopes for papillotomy.
Key Facts
- Recall date: January 7, 2026
- Quantity recalled: 1,474 units
- Hazard: Devices may deform and lose performance
- Immediate action required: Stop using the device
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Safety Guide
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