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-0725, Material REF: 5856930, 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
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 in endoscopic procedures such as papillotomy. It is designed for use with an Olympus endoscope and guidewire, enabling healthcare providers to perform precise surgical actions.
Why This Is Dangerous
The sphincterotome may deform if it did not undergo proper thermoforming. This deformation can lead to reduced performance and potential complications during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses significant risks to patient safety, necessitating immediate action from healthcare providers and patients.
Practical Guidance
How to identify if yours is affected
- Check the model number for KD-401Q-0725.
- Look for any signs of deformation in the device.
- Verify expiration date if applicable.
Where to find product info
You can typically find the model number and other identifiers on the device packaging or insert.
What timeline to expect
Expect a realistic timeline of 4-6 weeks for processing any refunds or replacements.
If the manufacturer is unresponsive
- Contact Olympus customer service again to follow up.
- Document all communications for your records.
- Consider filing a complaint with relevant health authorities if issues persist.
How to prevent similar issues
- Always verify product recalls before using medical devices.
- Look for safety certifications on medical equipment.
- Consult with healthcare professionals about the safest options available.
Documentation advice
Keep all purchase receipts, correspondence with the manufacturer, and any medical documentation related to the device.
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Product Details
The recalled product is the Disposable Triple Lumen Sphincterotome, Model/Catalog Number KD-401Q-0725. It was distributed worldwide, including nationwide in the US across multiple states. These devices are typically used with an Olympus endoscope and guidewire for papillotomy.
Key Facts
- Recalled Product: Disposable Triple Lumen Sphincterotome
- Model Number: KD-401Q-0725
- Quantity: 1,980 units recalled
- Distribution: Worldwide including US and International
- Hazard: Potential for deformation and performance loss
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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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