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
- Resection Sheath
- Model numbers
- Model No. A22041T, UDI: 04042761020978, 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 Resection Sheath is a medical device used in urologic applications. It is designed to assist in surgical procedures by allowing access to the urinary tract.
Why This Is Dangerous
The ceramic tip of the sheath may break during use, posing a risk of injury to patients undergoing procedures. This malfunction can lead to complications that require medical intervention.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the device immediately, which may disrupt ongoing medical treatments and require alternative solutions.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device to verify if it is Model No. A22041T.
- Inspect the packaging or documentation for any recall notice.
- Contact your healthcare provider for additional verification if uncertain.
Where to find product info
The model number and UDI can usually be found on the device packaging or the device itself near the manufacturer's label.
What timeline to expect
Expect a refund or replacement processing timeline of about 4-6 weeks.
If the manufacturer is unresponsive
- Document all correspondence with Olympus Corporation.
- Follow up via phone or email to ensure your request is being processed.
- Consider reporting the issue to the FDA if there is no response.
How to prevent similar issues
- Look for FDA recalls before purchasing medical devices.
- Check for safety certifications when selecting medical products.
- Consult with healthcare professionals about the reliability of devices used in procedures.
Documentation advice
Keep records of all communications, receipts, and any relevant documentation related to the recall.
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Product Details
The recalled product is the Olympus Resection Sheath, 24 Fr., with Deflecting Obturator, Model No. A22041T. The affected model includes all lots and has been distributed nationwide in the U.S.
Key Facts
- Model No. A22041T
- Nationwide distribution in the U.S.
- Ceramic tip may break during use
- Stop using immediately
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Safety Guide
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