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 Olympus Resection Sheath is a medical device used in urologic applications to assist in minimally invasive procedures. It is designed to help surgeons perform precise operations involving the urinary tract.
The risk arises from the potential for the ceramic tip of the resection sheath to break during use. Such failures can lead to complications, including additional surgical interventions or injury to the patient.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers and patients relying on this device for urologic procedures, necessitating immediate action to prevent potential harm.
The model number and UDI can typically be found on the device packaging or the device itself.
Expect processing for refunds or replacements to take approximately 4-6 weeks after contacting the manufacturer.
Keep all correspondence regarding the recall, including receipts and communications with Olympus.
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.
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