Olympus Corporation of the Americas recalled the Inner Sheath 21 Fr., Model No. A2660T, on November 11, 2025. The recall follows reports of the ceramic tip breaking during use. Patients and healthcare providers 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 Inner Sheath 21 Fr. Model No. A2660T is used in endoscopic procedures for diagnosis and treatment in urological applications. Healthcare providers use this device to perform minimally invasive surgeries.
The hazard arises from the ceramic tip of the resection sheath, which can break and pose injury risks during procedures. Patients may be at risk if the device fails during use.
This recall is not part of a broader industry pattern.
This recall presents a serious safety concern for patients undergoing urological procedures, potentially leading to injuries. It is critical that users stop using the device immediately to prevent adverse outcomes.
Find the model number and UDI on the device packaging or the device itself.
Expect a refund processing time of 4-6 weeks once your request is submitted.
Keep records of all communications, receipts, and any concerns related to the product.
The recalled product is the Olympus Inner Sheath 21 Fr., Model No. A2660T. It was distributed nationwide in the United States. The exact quantity recalled is one unit.
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