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-411Q-0730, Material REFs: (1) 5858230, (2) N6221731, (3) N6221740, UDI-DI: (1)04953170466557, (2)04953170466557, (3)04953170466557, 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 Disposable Triple Lumen Sphincterotome is a medical instrument used with an Olympus endoscope for papillotomy procedures. This device allows for the precise cutting of tissue using high-frequency current, making it crucial for various gastrointestinal interventions.
Why This Is Dangerous
The risk arises when the devices do not undergo proper thermoforming, resulting in potential deformation. This deformation can compromise the device's performance during critical medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall presents a significant risk to patient safety, requiring immediate cessation of use and potential medical procedure delays for those affected.
Practical Guidance
How to identify if yours is affected
- Check the model number KD-411Q-0730 on the packaging or the device itself.
- Verify if the device is part of the recalled batch based on the recall announcement.
- Confirm the expiration date to ensure it is valid.
Where to find product info
The model number and expiration date can typically be found on the device packaging or the device label itself.
What timeline to expect
Expect a refund or replacement process to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact Olympus Corporation directly for further assistance.
- Keep records of all communications regarding the recall.
How to prevent similar issues
- Always verify the model and batch number before use of medical devices.
- Check for recalls regularly on FDA or manufacturer websites.
Documentation advice
Document any communications with the manufacturer, including emails and phone call notes. Keep the product and packaging as evidence.
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Product Details
The recalled product is the Disposable Triple Lumen Sphincterotome, Model Number KD-411Q-0730. It was distributed worldwide, with 650 units sold in the United States and 237 units internationally.
Key Facts
- High hazard risk due to potential deformation
- Affected model: KD-411Q-0730
- Stop using immediately and contact manufacturer
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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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