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
- Single Use 3-Lumen Sphincterotome V
- Model numbers
- Model/Catalog Number: KD-V411M-0320, Material REF: (1) N1089430, (2) N1089410, (3) N5411130, UDI-DI: (1) 04953170183973, (2) 04953170466274, (3) 04953170380556, 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
February 18, 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 Single Use 3-Lumen Sphincterotome V is a medical device designed for use with an Olympus endoscope for papillotomy procedures. These instruments are critical for specific surgical procedures that require precise performance.
Why This Is Dangerous
Devices that did not undergo proper thermoforming can deform, leading to a loss of performance during medical use. This defect can endanger patient safety during procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must act quickly to ensure safety. The potential for device failure poses significant risks during medical procedures.
Practical Guidance
How to identify if yours is affected
- Check if the model number is KD-V411M-0320.
- Verify that your device has a valid expiration date.
- Consult with your healthcare provider if unsure about your device.
Where to find product info
The model number and expiration date can typically be found on the packaging or accompanying documentation of the device.
What timeline to expect
Expect a refund or replacement processing time of approximately 4 to 6 weeks.
If the manufacturer is unresponsive
- Document all correspondence with Olympus regarding the recall.
- Reach out to the FDA if you do not receive a timely response.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Look for FDA approval and certifications when purchasing medical equipment.
- Ensure devices are from reputable manufacturers with good safety records.
Documentation advice
Keep all relevant documentation, including purchase receipts, correspondence with the manufacturer, and records of any medical procedures involving the device.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, model KD-V411M-0320. It was distributed to healthcare facilities globally, including across 39 U.S. states. The total quantity recalled is 72,023 units.
Key Facts
- Recall initiated on January 7, 2026
- 72,023 units recalled globally
- Risk of device deformation and performance loss
- Immediate stop-use recommended
- Contact Olympus for further guidance
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Safety Guide
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