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-401Q-0720, Material REF: 5856830, UDI-DI: 04953170041648, 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 Disposable Triple Lumen Sphincterotome is a medical device used in endoscopic procedures for papillotomy using high-frequency current. Healthcare providers utilize this device to facilitate access to the bile duct during surgeries.
Why This Is Dangerous
The devices at risk did not undergo adequate thermoforming, which can lead to deformation during use. This deformation can compromise the effectiveness of the instrument during critical medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the affected devices to avoid complications in medical procedures, highlighting the need for prompt action.
Practical Guidance
How to identify if yours is affected
- Check the model number on the packaging or device to confirm if it is KD-401Q-0720.
- Review any notification letters received from Olympus regarding this recall.
- Contact Olympus or your healthcare provider for confirmation.
Where to find product info
Model numbers and lot numbers can usually be found on the packaging or directly on the device itself.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document all correspondence with Olympus regarding the recall.
- Reach out to the FDA or CPSC if you do not receive a response within a reasonable timeframe.
- Consider legal advice if you experience serious issues related to the product.
How to prevent similar issues
- Inquire about the quality assurance processes of medical devices before purchase.
- Ensure that devices are certified by relevant health authorities.
- Stay informed about recalls and safety notices from manufacturers.
Documentation advice
Keep copies of receipts, any recall notices from the manufacturer, and correspondence regarding the return process.
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Product Details
The recalled product is the Disposable Triple Lumen Sphincterotome, Model/Catalog Number KD-401Q-0720. It was distributed worldwide, including all U.S. states and internationally. The devices were sold as part of Olympus endoscope systems.
Key Facts
- Recall Date: January 7, 2026
- Hazard Level: High
- Affected Model: KD-401Q-0720
- Stop using immediately
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Safety Guide
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