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-VC431Q-0730, Material REF: (1) N5391610, (2) N5391630, (3) N5777930, UDI-DI: (1) 04953170466434, (2) 04953170466434, (3) 04953170466434, 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 Single Use 3-Lumen Sphincterotome V is a medical device designed for use during endoscopic procedures to aid in papillotomy. Healthcare professionals commonly use it to cut tissue with high-frequency current during these procedures.
Why This Is Dangerous
The device may deform if it did not undergo proper thermoforming, causing it to lose effectiveness during use. This can lead to complications in medical procedures, putting patients at risk.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face delays and complications related to their medical procedures if they have used the affected Sphincterotome. Immediate action is required to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device packaging or instruction manual.
- Check if your device is KD-VC431Q-0730.
- Verify if the device has a valid expiration date.
Where to find product info
The model number can typically be found on the device packaging or in the instruction manual.
What timeline to expect
Expect a refund or replacement to take approximately 4-6 weeks after processing your return.
If the manufacturer is unresponsive
- Contact Olympus Corporation directly for assistance.
- File a complaint with the FDA if there is no response.
How to prevent similar issues
- Always check for recall notices before using medical devices.
- Look for recent safety alerts from manufacturers before purchase.
- Ensure proper certification and safety compliance when selecting medical devices.
Documentation advice
Keep records of your purchase, return correspondence, and any communications with Olympus for your records.
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Product Details
The affected product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC431Q-0730. It was distributed worldwide, including 821 units in the U.S. and 3,362 units internationally.
Key Facts
- Recall date: January 7, 2026
- Quantity recalled: 4,183 units
- Affected catalog number: KD-VC431Q-0730
- Hazard level: High
- Immediate action required
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Safety Guide
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