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. Model No. A22041A, UDI: 04042761020961, 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 for surgical procedures. It is designed to facilitate the removal of tissue during surgeries.
Why This Is Dangerous
The device has been reported to have a defect where the ceramic tip may break during use. This poses a risk of injury to patients and complicates surgical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall impacts healthcare providers and patients who rely on this device for surgical procedures. The urgency to stop use is high due to the potential for serious injury.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device packaging or label.
- Check if your product matches Model No. A22041A.
- Verify if your product is among the recalled units.
Where to find product info
The model number and UDI can typically be found on the device packaging or accompanying documentation.
What timeline to expect
Expect a refund or replacement processing timeline of 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications regarding the recall.
- Follow up with Olympus Corporation if no response is received within a reasonable time frame.
- Consider filing a complaint with the FDA if the issue persists.
How to prevent similar issues
- When purchasing medical devices, check for safety certifications.
- Inquire about the manufacturer's track record for product recalls.
- Ensure the device has a reliable warranty and return policy.
Documentation advice
Keep copies of all correspondence regarding the recall, including emails and letters. Document any incidents or concerns related to the device.
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Product Details
The recalled product is the Olympus Resection Sheath, 24 Fr, Model No. A22041A. It is used for urologic applications. The sheath was distributed nationwide in the United States.
Key Facts
- Recalled product: Olympus Resection Sheath, 24 Fr
- Model No. A22041A
- Quantity recalled: 3,484 units
- Recall date: November 11, 2025
- High hazard level due to ceramic tip breaking
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