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-0720, Material REF: (1) N5391710, (2) N5391730, (3) N5778030, UDI-DI: (1) 04953170371219, (2) 04953170371219, (3) 04953170371219, 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 instrument designed for use with an Olympus endoscope during papillotomy procedures. Healthcare providers use this device to facilitate access and treatment in the biliary duct.
Why This Is Dangerous
The risk arises from devices that did not undergo proper thermoforming, which can lead to deformation and decreased performance. This can affect the efficacy of the device during critical medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall impacts healthcare providers and patients who rely on the device for medical procedures, creating urgency to address potential performance issues.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device: KD-VC433Q-0720.
- Verify if the device has a valid expiration date.
- Refer to the packaging or labeling for more information.
Where to find product info
Serial numbers and expiration dates are typically found on the device packaging or label.
What timeline to expect
Expect processing for refunds or replacements to take 4-6 weeks once the manufacturer receives the returned product.
If the manufacturer is unresponsive
- Document all correspondence with Olympus Corporation regarding the recall.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Research the manufacturer’s safety record before purchasing medical devices.
- Look for devices that are tested and certified by recognized safety organizations.
- Consult with healthcare professionals about the reliability of medical equipment.
Documentation advice
Keep a record of your purchase, any correspondence with the manufacturer, and photographs of the device as evidence.
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Product Details
The recalled product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number: KD-VC433Q-0720. The recall affects 350 units distributed in the U.S. and 1,154 units distributed internationally.
Key Facts
- Recall date: January 7, 2026
- Total quantity recalled: 1,504 units
- Hazard level: High
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Safety Guide
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