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. A22042T, UDI: 04042761020992, 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 used in urologic procedures to assist in surgical interventions. It is typically employed in procedures requiring tissue resection.
Why This Is Dangerous
The ceramic tip may break during use, which can lead to potential injuries during surgery. This defect raises concerns about patient safety in medical environments.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the device, which could disrupt planned medical procedures and necessitate alternative solutions.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device to confirm if it is A22042T.
- Look for the UDI code 04042761020992 on the packaging or the device.
- Verify the recall notice and match your purchase date against the recall timeline.
Where to find product info
The model number and UDI code are typically found on the product packaging or the device itself, usually near the base or handle.
What timeline to expect
Expect the recall resolution process to take approximately 4-6 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Contact Olympus customer service again for follow-up.
- Document your communications and consider filing a complaint with regulatory bodies.
How to prevent similar issues
- Consider safety certifications when purchasing medical devices.
- Research product reviews and safety records before use.
- Consult healthcare professionals about device alternatives.
Documentation advice
Keep all receipts, warranty information, and communications regarding the recall for future reference.
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Product Details
The recalled product is the Olympus Resection Sheath, model number A22042T, with UDI 04042761020992. It was distributed nationwide across the United States.
Key Facts
- Model No. A22042T
- Distribution: US Nationwide
- Stop using immediately
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Safety Guide
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