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. A42011A, UDI: 04042761023658, 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 Model No. A42011A is designed for use in gynecological procedures to aid in resection. Healthcare providers use this device to ensure safe and effective surgical outcomes.
Why This Is Dangerous
The breakage of the ceramic tip poses a risk of injury to patients during gynecological procedures. This defect can lead to complications if not addressed immediately.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face significant safety concerns due to the potential for injury. Immediate action is necessary to prevent any possible adverse effects.
Practical Guidance
How to identify if yours is affected
- Locate the model number A42011A on the device
- Check the UDI: 04042761023658
- Verify if your product is listed under the recalled units
Where to find product info
The model number and UDI can typically be found on the product packaging or the device itself.
What timeline to expect
Expect a timeline of 4-6 weeks for refund or replacement processing.
If the manufacturer is unresponsive
- Follow up with Olympus via phone or email
- Document all communication attempts
- Consider reaching out to the FDA for assistance
How to prevent similar issues
- Look for devices with robust materials that reduce breakage risk
- Check for FDA certifications when purchasing medical devices
- Purchase from reputable suppliers to ensure quality
Documentation advice
Document all correspondence regarding the recall, including emails and phone call logs. Keep your purchase receipt and any relevant medical records.
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Product Details
The Olympus Resection Sheath Model No. A42011A is used for gynecological applications. The product has a unique device identifier (UDI): 04042761023658. It was distributed nationwide in the U.S.
Key Facts
- Ceramic tip breakage risk
- Stop using immediately
- Contact Olympus for instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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