Olympus Corporation of the Americas recalled 3,484 units of the Resection Sheath Model No. A22041A on November 11, 2025. Reports indicate the ceramic tip of the device may break during use, posing a serious 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 Olympus Resection Sheath is a medical device used in urologic applications for surgical procedures. It is designed to facilitate the removal of tissue during surgeries.
The device has been reported to have a defect where the ceramic tip may break during use. This poses a risk of injury to patients and complicates surgical procedures.
This recall is not part of a broader industry pattern.
The recall impacts healthcare providers and patients who rely on this device for surgical procedures. The urgency to stop use is high due to the potential for serious injury.
The model number and UDI can typically be found on the device packaging or accompanying documentation.
Expect a refund or replacement processing timeline of 4-6 weeks.
Keep copies of all correspondence regarding the recall, including emails and letters. Document any incidents or concerns related to the device.
The recalled product is the Olympus Resection Sheath, 24 Fr, Model No. A22041A. It is used for urologic applications. The sheath was distributed nationwide in the United States.
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