Olympus Corporation of the Americas recalled 91 units of the Inner Sheath Model No. A4741 on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately and follow recall instructions.
Complaints of the ceramic tip of the resection sheath breaking have been received.
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
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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.
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.
This recall is not part of a broader industry pattern.
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.
The model number and UDI can typically be found on the device label or packaging.
Expect a refund or replacement processing time of approximately 4 to 6 weeks after following the return instructions.
Keep all receipts and correspondence about the product, as well as any documentation related to the recall.
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.
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