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-401Q-0320, Material REF: 5856630, UDI-DI: 04953170041587, 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
February 18, 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 Disposable Triple Lumen Sphincterotome is a medical instrument used for papillotomy, which is a procedure to remove stones from the bile duct. Healthcare providers use this device in conjunction with endoscopes to ensure precise operation during medical procedures.
Why This Is Dangerous
If the sphincterotome does not undergo proper thermoforming, it can deform, leading to reduced performance. This defect could compromise patient safety during medical use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this device for critical medical procedures face potential risks if the device is used. The urgency of the situation necessitates immediate action from healthcare providers to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging or the device.
- Verify if the model number is KD-401Q-0320.
- Look for any notice or letter from Olympus Corporation regarding the recall.
Where to find product info
The model number and relevant identifiers can usually be found on the packaging or directly on the device itself.
What timeline to expect
Expect refund processing to take 4-6 weeks once the return is initiated.
If the manufacturer is unresponsive
- Document all correspondence with the company.
- Contact regulatory bodies if you do not receive a response.
How to prevent similar issues
- Research medical devices before purchasing to ensure they meet safety standards.
- Seek recommendations from healthcare professionals about safe medical devices.
Documentation advice
Keep records of any communication with Olympus Corporation and your healthcare provider regarding the recall.
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Product Details
The recalled model is the KD-401Q-0320, which is designed for use with Olympus endoscopes and guidewires for papillotomy. The recall affects 999 units distributed worldwide, including across multiple U.S. states.
Key Facts
- Recall date: January 7, 2026
- High hazard level
- Distributed worldwide, including U.S. states
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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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