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. A2641, UDI: 04042761004060, 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. A2641 is designed for use in endoscopic procedures related to urological diagnoses and treatments. Healthcare providers use this device during surgeries to assist in the resection of tissue.
Why This Is Dangerous
The ceramic tip of the sheath can break during use, which may lead to serious complications or additional surgical interventions for patients. This malfunction poses a significant risk during endoscopic procedures, where precision is critical.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the device immediately to avoid potential injury. This recall may lead to delays in medical procedures requiring the sheath, impacting patient care.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device packaging or instruction manual.
- Verify if the device is Model No. A2641 from Olympus Corporation.
- Check for the UDI: 04042761004060 to confirm it is part of the recall.
Where to find product info
The model number and UDI can typically be found on the device itself, packaging, or accompanying documentation.
What timeline to expect
Expect processing for refunds or further instructions to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Reach out to Olympus Corporation customer service again.
- Document all communication attempts and seek assistance from healthcare providers.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Look for devices that have recent safety certifications and approvals.
Documentation advice
Keep records of your purchase, any communication with the manufacturer, and photos of the device for reference.
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Product Details
The Olympus Inner Sheath Model No. A2641 is used for endoscopic diagnosis and treatment in urological applications. It has been distributed nationwide in the U.S. The recall affects all lots of this model.
Key Facts
- Recalled product: Olympus Inner Sheath, Model No. A2641
- Recall date: November 11, 2025
- Patients advised to stop using the device immediately
- Ceramic tip breakage poses a high injury risk
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Safety Guide
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