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. A22043T, UDI: 04042761021012, 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 assists healthcare providers during surgical procedures and is valued for its precision.
Why This Is Dangerous
The ceramic tip of the resection sheath can break, which may result in injury to patients or healthcare providers during usage. This poses a significant safety risk.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients who may have used the device, necessitating immediate action to avoid potential injuries.
Practical Guidance
How to identify if yours is affected
- Verify the model number on the device as Model No. A22043T.
- Check if the device has the UDI: 04042761021012.
- Look for any notification letters from Olympus regarding this recall.
Where to find product info
The model number and UDI can typically be found on the device packaging or labeling.
What timeline to expect
Expect a timeline of approximately 4-6 weeks for processing refunds or replacements.
If the manufacturer is unresponsive
- Document all communication attempts with Olympus.
- Consider contacting the FDA if the issue persists.
How to prevent similar issues
- Look for products with robust safety certifications when purchasing medical devices.
- Consult with healthcare providers about device safety before use.
- Stay informed about recalls in the medical device industry.
Documentation advice
Keep copies of purchase receipts, recall notices, and any correspondence with the manufacturer.
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Product Details
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Distributed nationwide in the U.S. Quantity recalled: 207 units.
Key Facts
- Model No. A22043T
- Stop use immediately
- Follow manufacturer instructions
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