Olympus Corporation of the Americas recalled the Inner Sheath Model No. A2641 on November 11, 2025. The recall follows complaints of the ceramic tip breaking, posing a high risk of injury to patients. Healthcare providers and patients should 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. A2641 is used for endoscopic diagnosis and treatment in urological applications. It has been distributed nationwide in the U.S. The recall affects all lots of this model.
The ceramic tip of the resection sheath can break, presenting a high risk of injury during medical procedures. This defect can potentially lead to serious complications for patients undergoing urological treatments.
There have been complaints about the ceramic tip breaking, but no specific injury or incident counts have been reported at this time.
Stop using the Olympus Inner Sheath immediately. Contact the Olympus Corporation of the Americas or your healthcare provider for further instructions regarding the recall.
For further assistance, contact Olympus Corporation of the Americas at their customer service hotline or visit their official website. Recall notifications will be sent via letter.
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