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
- Unknown
- 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
- Resection Sheath
- Model numbers
- Model No. A2666, UDI: 04042761004244, All Lots
- Sold at
- Unknown
- 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 Resection Sheath is a medical device used in urologic procedures. It helps surgeons perform resection tasks effectively during surgeries.
Why This Is Dangerous
The ceramic tip of the resection sheath can break during surgical procedures, potentially leading to serious injuries such as lacerations.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses significant safety concerns for healthcare providers and patients. Immediate cessation of use is necessary to prevent injuries.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device.
- Verify that it matches Model No. A2666.
- Review packaging for any recall notifications.
Where to find product info
The model number can typically be found on the device itself or its packaging.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks after contacting Olympus.
If the manufacturer is unresponsive
- Document your communication attempts.
- Follow up with Olympus and escalate if necessary.
- Consider reaching out to regulatory authorities if no response is received.
How to prevent similar issues
- When purchasing medical devices, verify safety certifications.
- Avoid products with known failure rates.
- Consult peer reviews and professional recommendations.
Documentation advice
Keep records of your purchase, including receipts and any communication regarding the recall.
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Product Details
The recalled product is the Olympus Resection Sheath, Model No. A2666. The device is used for urologic applications. It was distributed across the U.S. and is classified as a Class II medical device.
Key Facts
- Model No. A2666
- Class II medical device
- Recalled on November 11, 2025
- High hazard level
- Stop using immediately
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Safety Guide
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