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
- Endoscopic Sheath
- Model numbers
- Model No. A4741, UDI: 04042761006514, 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 Inner Sheath Model No. A4741 is used in medical settings for endoscopic procedures, particularly in gynecology. Healthcare professionals use this device to assist with diagnostic and therapeutic interventions.
Why This Is Dangerous
The device's ceramic tip can break during medical procedures, which increases the risk of internal injury to patients. This poses a significant safety concern for both patients and healthcare providers.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients relying on this medical device for gynecological procedures. Immediate cessation of use is necessary to prevent potential injuries.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device packaging or label.
- Verify the UDI: 04042761006514 to check if your device is affected.
- Confirm that your device is part of the recalled lots.
Where to find product info
The model number and UDI can typically be found on the device label or packaging.
What timeline to expect
Expect a refund or replacement processing time of approximately 4 to 6 weeks after following the return instructions.
If the manufacturer is unresponsive
- Document your communications with Olympus.
- Reach out to the consumer protection agency if the company does not respond.
- Consider seeking legal advice if the situation remains unresolved.
How to prevent similar issues
- Always check for recalls before purchasing medical devices.
- Look for FDA clearance or approval notifications.
- Consult with healthcare professionals about device safety and recalls.
Documentation advice
Keep all receipts and correspondence about the product, as well as any documentation related to the recall.
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Product Details
The recalled product is the Olympus Inner Sheath, Model No. A4741, used for endoscopic diagnosis and treatment in gynecological applications. It was distributed nationwide across the U.S. and has a unique device identifier (UDI) of 04042761006514.
Key Facts
- Model No. A4741
- High hazard level
- Stop use immediately
- Contact Olympus for instructions
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Safety Guide
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