Olympus Corporation of the Americas recalled the Inner Sheath Model No. A2660 on November 11, 2025. Complaints of the ceramic tip breaking prompted the recall of nine units distributed nationwide. Patients and healthcare providers must stop using the device immediately.
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 recall involves the Olympus Inner Sheath, Model No. A2660, used for endoscopic diagnosis and treatment in urological applications. The product is distributed nationwide in the U.S. and is classified as a Class II medical device.
The ceramic tip of the resection sheath may break during use, posing a risk of injury to patients. This defect could lead to complications during medical procedures, resulting in potential harm.
There have been multiple complaints regarding the ceramic tip breaking. No specific injury count has been reported.
Stop using the product immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions regarding the recall.
For more information, reach Olympus Corporation of the Americas at their official website or call their customer service.
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