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-V411M-3020, Material REF: N1090110, UDI-DI: N/A, 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 with Olympus endoscopes during papillotomy procedures. Healthcare providers choose this device for its precision in biliary procedures.
Why This Is Dangerous
Improper thermoforming can lead to deformation of the device, which may compromise its performance during critical medical procedures. This risk is significant in clinical settings where device reliability is crucial.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers who rely on these devices for safe and effective patient care. Immediate action is necessary to prevent potential risks during medical procedures.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging for KD-V411M-3020.
- Verify the expiration date to determine if your device is affected.
- Confirm if the device was distributed within the recall period.
Where to find product info
Model numbers can be found on the packaging and accompanying documentation.
What timeline to expect
Expect processing for refunds or replacements to take 4-6 weeks after submission.
If the manufacturer is unresponsive
- Document all communications with Olympus regarding the recall.
- Contact the FDA if Olympus does not respond within a reasonable timeframe.
- Consider reaching out through social media for faster response.
How to prevent similar issues
- Verify safety certifications like CPSC for medical devices before purchase.
- Research recalls and safety reports for medical devices.
- Consult healthcare professionals for recommendations on reliable alternatives.
Documentation advice
Keep records of receipts, correspondence with Olympus, and photos of the product as evidence for your records.
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Product Details
The affected product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-V411M-3020. Olympus distributed this product Worldwide, including 50 states in the US. The recall affects 650 units.
Key Facts
- Recall date: January 7, 2026
- High risk of performance failure
- Used in medical procedures with Olympus endoscopes
- Immediate action required
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Safety Guide
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