Olympus Corporation of the Americas recalled 2,626 units of its Resection Sheath on November 11, 2025. The ceramic tip of the sheath 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 recalled product is the Olympus Resection Sheath, 24 Fr., with Deflecting Obturator, Model No. A22041T. The affected model includes all lots and has been distributed nationwide in the U.S.
The ceramic tip of the resection sheath has been reported to break, which could lead to serious complications during urologic procedures. This recall has been classified as Class II, indicating that use of the product may lead to temporary or medically reversible adverse health consequences.
There have been multiple complaints regarding the breaking of the ceramic tip, although no specific injury or incident counts have been reported at this time.
Patients and healthcare providers should immediately stop using the resection sheath. They should contact Olympus Corporation of the Americas or their healthcare provider for further instructions. Follow the recall instructions provided by the manufacturer.
For further details, contact Olympus Corporation of the Americas directly or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1442-2026.
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