Olympus Corporation of the Americas recalled 6,949 units of its Resection Inner Sheath on November 11, 2025, after reports of the ceramic tip breaking. This device, used in urologic applications, poses a high hazard risk. Healthcare providers and patients should 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 Olympus Resection Inner Sheath is used in urologic applications during surgical procedures. It allows for precise tissue removal and is critical for effective medical treatment.
The ceramic tip of the sheath may break during use, leading to potential injuries during surgical procedures. This defect compromises patient safety significantly.
This recall is not part of a broader industry pattern.
Patients using this device may face serious safety risks, necessitating immediate action to prevent potential complications during procedures.
Find the model number on the outer packaging or the device itself, usually near the handle or body of the sheath.
Expect a refund or replacement processing time of approximately 4-6 weeks.
Keep records of all correspondence regarding the recall, including photos of the device and any medical documentation.
The recalled product is the Olympus Resection Inner Sheath, Model No. A22040A. It was distributed nationwide in the United States. The device is typically used in urologic procedures.
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