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. A22040A, UDI: 04042761029339, 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 Inner Sheath is used in urologic applications during surgical procedures. It allows for precise tissue removal and is critical for effective medical treatment.
Why This Is Dangerous
The ceramic tip of the sheath may break during use, leading to potential injuries during surgical procedures. This defect compromises patient safety significantly.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using this device may face serious safety risks, necessitating immediate action to prevent potential complications during procedures.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device.
- Check if it is Model No. A22040A.
- Verify the UDI: 04042761029339.
Where to find product info
Find the model number on the outer packaging or the device itself, usually near the handle or body of the sheath.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact Olympus Corporation directly for further assistance.
- Document all communication attempts with Olympus.
How to prevent similar issues
- Choose medical devices that are thoroughly tested for safety.
- Consult healthcare providers about the latest safety standards for medical devices.
Documentation advice
Keep records of all correspondence regarding the recall, including photos of the device and any medical documentation.
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Product Details
The recalled product is the Olympus Resection Inner Sheath, Model No. A22040A. It was distributed nationwide in the United States. The device is typically used in urologic procedures.
Key Facts
- Model No. A22040A
- Total recall of 6,949 units
- Stop using immediately
- Contact Olympus for further instructions
- High hazard classification
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