Olympus Corporation of the Americas recalled 6,949 units of its Resection Inner Sheath on November 11, 2025, after reports of the ceramic tip breaking. This device, used in urologic applications, poses a high hazard risk. Healthcare providers and patients should 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 Inner Sheath, Model No. A22040A. It was distributed nationwide in the United States. The device is typically used in urologic procedures.
The recall stems from reports of the ceramic tip of the resection sheath breaking. This defect could potentially lead to serious complications during medical procedures.
There have been several complaints about the ceramic tip breaking, but specific incident numbers were not disclosed. The high hazard classification indicates a significant risk to patient safety.
Patients and healthcare providers should stop using the device immediately. They should follow the recall instructions provided by Olympus Corporation and contact their healthcare provider for guidance.
For more information, contact Olympus Corporation of the Americas. Visit their website or refer to the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1439-2026.
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