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
- Disposable Triple Lumen Sphincterotome
- Model numbers
- Model/Catalog Number: KD-401Q-0730, Material REF: 5857030, UDI-DI: 04953170041709, 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 device used during endoscopic procedures, particularly for papillotomy. These devices enable precise cutting and access to the biliary duct using high-frequency current.
Why This Is Dangerous
Improper thermoforming of the device can lead to deformation, which may compromise its performance during critical medical procedures. This raises the risk of ineffective treatment or patient harm.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act swiftly to avoid using potentially compromised devices, ensuring safety during medical procedures.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device packaging or the device itself.
- Verify if the model number matches KD-401Q-0730.
- Check for any notifications or letters from Olympus regarding the recall.
Where to find product info
The model number can typically be found on the packaging or directly on the device.
What timeline to expect
Expect a processing time of approximately 4-6 weeks for refunds or replacements after returning the device.
If the manufacturer is unresponsive
- Keep a record of all correspondence with the manufacturer.
- Reach out to the FDA if the company does not respond.
How to prevent similar issues
- Always check for recall notices before using medical devices.
- Ensure devices are purchased from reputable sources.
- Inquire about the latest safety information from manufacturers.
Documentation advice
Document all communications regarding the recall, including phone calls and letters, and keep a copy of the return shipment receipt.
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Product Details
The recalled product is the Disposable Triple Lumen Sphincterotome, Model/Catalog Number: KD-401Q-0730. It is designed for use with an Olympus endoscope and guidewire for papillotomy using high-frequency current. The affected units were distributed worldwide, including across multiple U.S. states.
Key Facts
- Risk of device deformation
- Class II medical device
- Stop using immediately
- Notification via letter
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Safety Guide
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