Quick Facts at a Glance
- Recall Date
- November 11, 2025
- 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
- Endoscopic Sheath
- Model numbers
- Model No. A2660T, UDI: 04042761004183, All Lots.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 11, 2025
Reported by FDA DEVICE
March 4, 2026
RecallRadar source check
March 11, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Complaints of the ceramic tip of the resection sheath breaking have been received.
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 Olympus Inner Sheath 21 Fr. Model No. A2660T is used in endoscopic procedures for diagnosis and treatment in urological applications. Healthcare providers use this device to perform minimally invasive surgeries.
Why This Is Dangerous
The hazard arises from the ceramic tip of the resection sheath, which can break and pose injury risks during procedures. Patients may be at risk if the device fails during use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall presents a serious safety concern for patients undergoing urological procedures, potentially leading to injuries. It is critical that users stop using the device immediately to prevent adverse outcomes.
Practical Guidance
How to identify if yours is affected
- Verify the model number on your device
- Check for the UDI: 04042761004183
- Ensure your device is from the affected lot
Where to find product info
Find the model number and UDI on the device packaging or the device itself.
What timeline to expect
Expect a refund processing time of 4-6 weeks once your request is submitted.
If the manufacturer is unresponsive
- Follow up with Olympus customer service
- Document all communication attempts
- Consider filing a complaint with the FDA if no response
How to prevent similar issues
- Look for devices with high safety ratings
- Check for recent recalls before purchase
- Consult healthcare professionals about device safety
Documentation advice
Keep records of all communications, receipts, and any concerns related to the product.
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Product Details
The recalled product is the Olympus Inner Sheath 21 Fr., Model No. A2660T. It was distributed nationwide in the United States. The exact quantity recalled is one unit.
Key Facts
- Model No. A2660T affected
- Ceramic tip breakage hazard
- Stop using immediately
- Contact Olympus for instructions
- Nationwide distribution in the U.S.
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Safety Guide
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