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. A22042A, UDI: 04042761020985, 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 to assist in minimally invasive procedures. It is designed to help surgeons perform precise operations involving the urinary tract.
Why This Is Dangerous
The risk arises from the potential for the ceramic tip of the resection sheath to break during use. Such failures can lead to complications, including additional surgical interventions or injury to the patient.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients relying on this device for urologic procedures, necessitating immediate action to prevent potential harm.
Practical Guidance
How to identify if yours is affected
- Check the model number on your Resection Sheath to see if it matches Model No. A22042A.
- Verify if the Unique Device Identifier (UDI) is 04042761020985 on the device packaging.
- Contact your healthcare provider to confirm if your device is affected.
Where to find product info
The model number and UDI can typically be found on the device packaging or the device itself.
What timeline to expect
Expect processing for refunds or replacements to take approximately 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document your communication attempts with Olympus Corporation.
- Consider following up with your healthcare provider for assistance.
- File a complaint with the FDA if you do not receive a response.
How to prevent similar issues
- Look for medical devices with higher safety standards and FDA approval.
- Inquire about the materials used in medical devices, preferring those with proven durability.
- Stay informed about recalls from manufacturers and regulatory agencies.
Documentation advice
Keep all correspondence regarding the recall, including receipts and communications with Olympus.
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Product Details
The recall affects Olympus Resection Sheath, 26 Fr.; Model No. A22042A. The product was distributed nationwide in the U.S. The affected units have a Unique Device Identifier: 04042761020985.
Key Facts
- Recall date: November 11, 2025
- Quantity recalled: 1,676 units
- Model No. A22042A affected
- Nationwide distribution in the US
- Immediate action required to stop use
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