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-0720, Material REF: 5858030, UDI-DI: Under Review, 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 for papillotomy procedures. It is designed for use with an Olympus endoscope to facilitate the safe removal of stones from the bile duct.
Why This Is Dangerous
The devices may not have undergone proper thermoforming, leading to potential deformation. This can compromise their effectiveness and safety during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall necessitates immediate action from healthcare providers and patients, potentially disrupting scheduled procedures and affecting patient care.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device packaging or documentation.
- Verify if the product falls within the recalled model KD-411Q-0720.
- Look for any expiration date on the product to confirm its validity.
Where to find product info
You can find the model number and expiration date on the packaging or the product itself.
What timeline to expect
A realistic timeline for processing refunds or replacements is typically 4-6 weeks.
If the manufacturer is unresponsive
- Document your communication attempts with Olympus.
- Consider reaching out again via different contact methods.
- Consult your healthcare provider for further assistance.
How to prevent similar issues
- When purchasing medical devices, check for FDA approval and recall history.
- Ensure proper handling and storage of sensitive medical devices to maintain integrity.
- Stay informed about recalls via official health and safety websites.
Documentation advice
Keep all correspondence regarding the recall, including emails, letters, and any documentation related to the purchase and use of the device.
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Product Details
The recalled product is the Disposable Triple Lumen Sphincterotome, Model KD-411Q-0720. It was distributed worldwide, including in 7 units in the US and 118 units internationally. This device is designed for use with an Olympus endoscope for papillotomy.
Key Facts
- Recall date: January 7, 2026
- Total recalled units: 125
- Risk of device deformation and performance loss
- Affected model: KD-411Q-0720
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Safety Guide
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