Olympus recalled 94 units of its 10 Fr. endoscopic sheath on November 11, 2025, due to complaints of the ceramic tip breaking. The defect poses a high risk for patients undergoing urological procedures. Healthcare providers and patients 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 affected product is the Olympus Sheath, model number A37004A, with UDI 04042761023092. The sheath is designed for endoscopic diagnosis and treatment in urological applications and was distributed nationwide in the U.S.
The recall stems from complaints regarding the ceramic tip of the resection sheath breaking during use. This issue presents a high risk to patients, as it may lead to injury during medical procedures.
There have been no reported injuries or deaths associated with this product. However, the risk of the ceramic tip breaking necessitates immediate action.
Patients and healthcare providers should stop using the sheath immediately. Follow the recall instructions provided by Olympus Corporation of the Americas and contact your healthcare provider for guidance.
For further assistance, contact Olympus Corporation of the Americas. Visit their website or call their customer service.
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