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-431Q-0720, Material REF: (1) 5859230, (2) N6221831, (3) N6221840, UDI-DI: (1) 04953170042362, (2) 04953170463778, (3) 04953170466564, 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 used in medical procedures involving the biliary and pancreatic ducts. It is designed to facilitate papillotomy using high-frequency current.
Why This Is Dangerous
The failure of the device to undergo proper thermoforming may compromise its structural integrity, leading to deformation and performance issues during use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall could disrupt medical procedures where the device was intended to be used, posing safety concerns that require immediate action.
Practical Guidance
How to identify if yours is affected
- Locate the model number KD-431Q-0720 on the device or packaging.
- Check for the UDI-DI numbers listed in the recall notice.
- Verify if your device was purchased through a healthcare provider.
Where to find product info
Model numbers and UDI-DI numbers can typically be found on the packaging of the device or on the device label itself.
What timeline to expect
Refund processing may take 4-6 weeks once the returned device is received.
If the manufacturer is unresponsive
- Keep records of all communications with Olympus and your healthcare provider.
- Contact the FDA for further assistance if the company does not respond.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Consider alternative brands with a solid safety record in medical devices.
- Ensure that devices have undergone necessary quality checks prior to use.
Documentation advice
Keep all documentation related to the recall, including receipts, correspondence, and photos of the device.
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Product Details
The recalled product is the Disposable Triple Lumen Sphincterotome, Model/Catalog Number KD-431Q-0720. It was distributed globally, including 7,501 units in the U.S. The devices were sold through various healthcare providers.
Key Facts
- Model/Catalog Number: KD-431Q-0720
- Distributed worldwide, including 50 U.S. states
- Risk of device deformation
- Immediate action required
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Safety Guide
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