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 Sphincterotome
- Model numbers
- Model/Catalog Number: KD-VC431Q-0720, Material REF: (1) N5391530, (2) N5391510, (3) N5777830, UDI-DI: (1) 04953170466427, (2) 04953170466427, (3) 04953170466427, 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 Sphincterotome V is a medical instrument designed for use during endoscopic procedures to facilitate papillotomy. Healthcare providers utilize this device to aid in the treatment of various gastrointestinal conditions.
Why This Is Dangerous
Improper thermoforming during manufacturing can cause these devices to deform, compromising their functionality and safety during procedures. This issue can lead to significant risks in patient care.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this device for medical procedures face potential safety risks. Healthcare providers must act quickly to halt usage and ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the packaging or device.
- Verify the model number against the recalled model KD-VC431Q-0720.
- Check for any correspondence from Olympus regarding the recall.
Where to find product info
The model number is typically found on the device packaging or printed on the device itself.
What timeline to expect
Expect a 4-6 week timeline for processing refunds or replacements following the recall instructions.
If the manufacturer is unresponsive
- Contact Olympus Corporation directly for assistance.
- Document all communication attempts with the company.
How to prevent similar issues
- Always check for recall notices on medical devices before use.
- Ensure that medical devices are sourced from reputable suppliers.
Documentation advice
Keep records of your purchase, any communications with Olympus, and photos of the device if required for the recall process.
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Product Details
The affected model is the Single Use Sphincterotome V, Model/Catalog Number: KD-VC431Q-0720. These devices were distributed worldwide, including 8,789 units in the U.S. They are designed for use with Olympus endoscopes and guidewires for papillotomy, using high-frequency current.
Key Facts
- Recall date: January 7, 2026
- 12,641 units recalled globally
- High risk of performance failure
- Contact Olympus for further instructions
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Safety Guide
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