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-0330, Material REF: 5856730, UDI-DI: 04953170041617, 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 in endoscopic procedures for papillotomy with high-frequency current. Healthcare providers commonly use this instrument to facilitate procedures requiring precise access to the bile duct.
Why This Is Dangerous
The devices may lose their performance due to inadequate thermoforming, leading to potential malfunction during use. This poses a risk to patient safety during medical interventions.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers who rely on this device for critical procedures. The potential for device malfunction could lead to complications during surgery, urging immediate action.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging or device to confirm it is KD-401Q-0330.
- Verify the expiration date to ensure it is valid.
- Contact your healthcare provider for confirmation if unsure.
Where to find product info
The model number and expiration date are typically located on the device packaging or the device itself, often printed or labeled clearly.
What timeline to expect
Expect a refund or replacement processing timeframe of 4-6 weeks after submission.
If the manufacturer is unresponsive
- Follow up with Olympus customer support via phone or email.
- Document your communication attempts for reference.
How to prevent similar issues
- When purchasing medical devices, ensure they meet regulatory standards and certifications.
- Request information on quality control measures during manufacturing.
Documentation advice
Keep copies of receipts, any correspondence with the manufacturer, and photos of the device for your records.
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Product Details
The recalled product is the Disposable Triple Lumen Sphincterotome with model number KD-401Q-0330. It was distributed worldwide, including all 50 US states. The devices are designed for use with Olympus endoscopes and guidewires.
Key Facts
- Recall date: January 7, 2026
- Reported date: February 11, 2026
- Quantity recalled: 886 units
- Class II medical device
- Affected model: KD-401Q-0330
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Safety Guide
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