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: A22014A (UDI: 04042761020893) and A22014T (UDI: 04042761020909). 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 for endoscopic procedures in urology. Healthcare providers utilize it for diagnostic and treatment purposes during minimally invasive surgeries.
Why This Is Dangerous
The device has a ceramic tip that is prone to breaking during use, which can lead to complications for patients. This defect necessitated the recall to prevent potential injuries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall may disrupt medical procedures and necessitate adjustments for healthcare providers and patients who rely on this device.
Practical Guidance
How to identify if yours is affected
- Check the model number on your device; affected models are A22014A and A22014T.
- Consult your healthcare provider to confirm if your device is affected.
Where to find product info
The model and UDI numbers can typically be found on the packaging or the device itself.
What timeline to expect
Expect 4-6 weeks for refund processing once the recalled device is returned to Olympus.
If the manufacturer is unresponsive
- Document all attempts to contact Olympus.
- Consider reaching out to regulatory bodies such as the FDA if there is no response.
How to prevent similar issues
- When purchasing medical devices, ensure they have updated safety certifications.
- Check for recalls related to similar products before use.
- Consult with healthcare providers about the safety and efficacy of medical devices.
Documentation advice
Keep receipts, correspondence with Olympus, and records of any incidents associated with the device.
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Product Details
The recalled products are Olympus Resection Sheath, Model No. A22014A and A22014T. The devices are used for endoscopic diagnosis and treatment in urological applications. They were distributed nationwide in the United States.
Key Facts
- Models A22014A and A22014T affected
- Ceramic tip may break during use
- Class II recall issued
- Contact Olympus for further instructions
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Safety Guide
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