Olympus Corporation recalled 899 units of the Resection Sheath Model No. A42011A on November 11, 2025. Complaints indicate that the ceramic tip may break during use, posing a high risk to patients. 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 Olympus Resection Sheath Model No. A42011A is used for gynecological applications. The product has a unique device identifier (UDI): 04042761023658. It was distributed nationwide in the U.S.
The ceramic tip of the resection sheath can break, which poses a risk of injury to patients during gynecological procedures. This recall falls under Class II, indicating a potential for serious adverse health consequences.
The recall was initiated following multiple complaints regarding breakage of the ceramic tip. As of now, no specific injuries have been reported.
Healthcare providers and patients should stop using the resection sheath immediately. Follow the manufacturer's recall instructions and contact Olympus Corporation of the Americas or your healthcare provider for further guidance.
For more information, contact Olympus Corporation of the Americas at [insert contact number]. Visit the recall notice at the FDA website for details.
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