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-VC433Q-0730, Material REF: (1) N5391830, (2) N5391810, (3) N5778130, UDI-DI: (1) 04953170371233, (2) 04953170371233, (3) 04953170371233, 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 used for papillotomy in endoscopic procedures. It facilitates access to the bile duct for treatments using high-frequency current.
Why This Is Dangerous
If the sphincterotome has not undergone thermoforming, it can deform during use. This deformation may impair its effectiveness and pose serious risks during surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may face delays in treatment due to the recall. Healthcare providers must ensure they have safe alternatives available to avoid compromising patient care.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device or packaging.
- Verify if the model number is KD-VC433Q-0730.
- Consult your healthcare provider for assistance.
Where to find product info
Look for the model number on the device packaging or the device itself, typically near the serial number or on the label.
What timeline to expect
4-6 weeks for refund processing after returning the device.
If the manufacturer is unresponsive
- Contact Olympus customer service again for follow-up.
- Document all communications and consider filing a complaint with regulatory agencies.
How to prevent similar issues
- Ensure devices have proper certifications before purchasing.
- Check for recalls regularly on medical devices you use.
- Consult with healthcare providers about the latest device safety information.
Documentation advice
Document all correspondence regarding the recall, keep receipts for any returned products, and take photos of the device.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model Number KD-VC433Q-0730. It was designed for use with Olympus endoscopes for papillotomy. The devices were distributed worldwide, including across multiple U.S. states.
Key Facts
- Recall date: January 7, 2026
- Quantity recalled: 93 units
- Risk level: High
- Affected model: KD-VC433Q-0730
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.