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-V431M-0730, Material REF: (1) N1090530, (2) N1090510, (3) N5412030, UDI-DI: (1) 04953170380648, (2) 04953170380648, (3) 04953170380648, 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 designed for use with Olympus endoscopes in papillotomy procedures. It utilizes high-frequency current to perform the procedure effectively.
Why This Is Dangerous
The devices may deform if they did not undergo proper thermoforming, which can lead to malfunction during critical medical procedures. This could compromise patient safety and treatment effectiveness.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients who rely on these devices for endoscopic procedures. Users must act promptly to avoid potential risks and ensure safety.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging or device.
- Verify if the model number is KD-V431M-0730.
- Confirm if the product was purchased recently.
Where to find product info
The model number is typically found on the product packaging or directly on the device.
What timeline to expect
Expect processing for refunds or replacements to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact Olympus customer service again.
- Document your communications and any responses received.
- Consider reaching out to the FDA if concerns persist.
How to prevent similar issues
- Look for devices with proper safety certifications.
- Ensure the product has undergone quality checks before purchase.
- Consult with healthcare professionals on reliable medical devices.
Documentation advice
Keep records of purchase receipts, recall notices, and correspondence with Olympus for reference.
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Product Details
The recall involves Single Use 3-Lumen Sphincterotome V, Model KD-V431M-0730. Olympus distributed 2,411 units in the U.S. and 15,244 units internationally.
Key Facts
- Recall date: January 7, 2026
- Total units recalled: 17,655
- Distribution: U.S. and worldwide
- Affected model: KD-V431M-0730
- Classification: Class II
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Safety Guide
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