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. A22040T, UDI: 04042761029360, 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 A22040T resection sheath is used in urologic applications to assist in surgical procedures. Consumers purchase this device for its intended use in minimally invasive surgeries.
Why This Is Dangerous
The defect arises from the ceramic tip, which can break during use, risking injury to patients. The breakage poses a significant hazard during delicate urologic operations.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall requires immediate action from healthcare professionals and patients, impacting surgical schedules and requiring alternative solutions.
Practical Guidance
How to identify if yours is affected
- Check if your device is Model No. A22040T
- Verify the UDI number 04042761029360
- Look for any notification letters from Olympus regarding the recall.
Where to find product info
The model number and UDI can usually be found on the packaging or the device itself.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing.
If the manufacturer is unresponsive
- Follow up with Olympus through customer service.
- Document all interactions and keep a record of your communications.
How to prevent similar issues
- Look for devices with FDA approval and safety certifications in the future.
- Ask healthcare providers about the safety record of similar devices before use.
- Consider alternative products with proven reliability.
Documentation advice
Keep records of your purchase, including receipts and any correspondence related to the recall.
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Product Details
The recalled product is the Olympus Resection Inner Sheath for 26 Fr. Outer Sheath, Model No. A22040T. The device was distributed nationwide in the United States.
Key Facts
- Recall date: November 11, 2025
- Model No.: A22040T
- Quantity recalled: 7,426 units
- High hazard level due to breakage risk
- Nationwide distribution in the US
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Safety Guide
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