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 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.
Complaints indicate that the ceramic tip of the resection sheath may break during use. This defect can lead to potential harm during medical procedures, heightening the risk of injury.
There are no specific injury counts reported, but the high hazard classification indicates a serious risk associated with the device. Users should heed all warnings regarding its use.
Stop using the Olympus Inner Sheath immediately. Contact Olympus Corporation of the Americas or your healthcare provider for instructions on returning the product.
For more information, patients and healthcare providers can visit the Olympus website or call their customer service line at 1-800-XXX-XXXX.
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