Olympus Corporation recalled 29 units of its Resection Sheath on November 11, 2025. The recall affects model numbers A22014A and A22014T due to complaints of the ceramic tip breaking. The company advises immediate cessation of use and adherence to 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 Resection Sheath is a medical device used for endoscopic procedures in urology. Healthcare providers utilize it for diagnostic and treatment purposes during minimally invasive surgeries.
The device has a ceramic tip that is prone to breaking during use, which can lead to complications for patients. This defect necessitated the recall to prevent potential injuries.
This recall is not part of a broader industry pattern.
The recall may disrupt medical procedures and necessitate adjustments for healthcare providers and patients who rely on this device.
The model and UDI numbers can typically be found on the packaging or the device itself.
Expect 4-6 weeks for refund processing once the recalled device is returned to Olympus.
Keep receipts, correspondence with Olympus, and records of any incidents associated with the device.
The recalled products are Olympus Resection Sheath, Model No. A22014A and A22014T. The devices are used for endoscopic diagnosis and treatment in urological applications. They were distributed nationwide in the United States.
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