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
- Unknown
- 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
- Endoscopic Sheath
- Model numbers
- Model No. A2642, UDI: 04042761004084, All Lots.
- Sold at
- Unknown
- 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 Inner Sheath, Model No. A2642, is utilized in endoscopic procedures for urological diagnosis and treatment. Healthcare providers use this device to facilitate minimally invasive surgeries.
Why This Is Dangerous
The ceramic tip of the resection sheath can break during use, posing risks of injury to patients. This defect can compromise the effectiveness of procedures and lead to complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall affects healthcare providers and patients relying on this device for urological procedures. The immediate halt in use may disrupt medical services and patient care.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device.
- Check for the UDI: 04042761004084.
- Confirm if the device is part of the recall by comparing to the provided model number.
Where to find product info
The model number can typically be found on the device packaging or labeling.
What timeline to expect
Expect processing of refunds or replacements to take several weeks after the recall notification.
If the manufacturer is unresponsive
- Contact Olympus Corporation directly for assistance.
- Reach out to your healthcare provider for further guidance.
How to prevent similar issues
- Always check for product recalls before use of medical devices.
- Ensure devices have up-to-date safety certifications and reports.
Documentation advice
Keep records of your purchase, any correspondence with Olympus, and notes on the recall for your documentation.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is the Olympus Inner Sheath, Model No. A2642. It is used for endoscopic diagnosis and treatment in urological applications. The product was distributed nationwide in the US.
Key Facts
- Recall date: November 11, 2025
- Model No. A2642
- High hazard level
- Nationwide distribution in the US
- No injuries reported
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.