Olympus Corporation of the Americas recalled 1,676 units of Resection Sheath Model No. A22042A on November 11, 2025. Complaints indicated the ceramic tip of the sheath could break during use, posing a hazard to patients. Healthcare providers and patients must 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 recall affects Olympus Resection Sheath, 26 Fr.; Model No. A22042A. The product was distributed nationwide in the U.S. The affected units have a Unique Device Identifier: 04042761020985.
The ceramic tip of the resection sheath has been reported to break during use. This defect could potentially lead to serious complications in urologic procedures.
The recall follows multiple complaints regarding the breaking of the ceramic tip. As of the recall date, no specific injury counts have been reported.
Patients and healthcare providers should stop using the device immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions.
For more information, reach Olympus Corporation of the Americas at their official website or through the provided recall notification letter.
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