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. A2660, UDI: 04042761004176, 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 Model No. A2660 is used in endoscopic procedures for diagnosis and treatment in urology. It is designed to assist healthcare professionals during minimally invasive surgeries.
Why This Is Dangerous
The ceramic tip of the resection sheath can break, which may lead to complications in surgical procedures. This defect creates a risk for patients undergoing urological treatments.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face potential safety risks, necessitating immediate action to stop using the device and follow recall instructions.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device to see if it is Model No. A2660.
- Review any purchase documentation or serial numbers related to the device.
- Contact your healthcare provider if you are unsure about your device's model.
Where to find product info
The model number can typically be found on the packaging or the device itself.
What timeline to expect
Expect to receive further instructions and information regarding refund processing within 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Olympus customer service if you do not receive a response within a week.
- Document all communications you have with the company.
How to prevent similar issues
- When purchasing medical devices, ensure they are certified and have no recent recalls.
- Stay informed about product recalls through official health organizations.
- Consult with healthcare professionals about the safety of devices being used.
Documentation advice
Keep all records of communications regarding the recall, including emails, letters, and any medical documentation of issues.
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Product Details
The recall involves the Olympus Inner Sheath, Model No. A2660, used for endoscopic diagnosis and treatment in urological applications. The product is distributed nationwide in the U.S. and is classified as a Class II medical device.
Key Facts
- Olympus Inner Sheath Model No. A2660 recalled
- Ceramic tip may break during use
- Nine units affected in the recall
- Class II medical device
- Stop use immediately and follow recall instructions
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Safety Guide
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