Olympus Corporation of the Americas recalled 118 units of its 28 Fr. resection sheath on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a risk of injury. 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, Model No. A22043A. It is intended for urologic applications. The devices were distributed nationwide in the U.S.
The recall stems from complaints regarding the ceramic tip of the resection sheath breaking. This defect can pose a significant risk during medical procedures, potentially resulting in injury.
The recall has been classified as Class II, indicating a high hazard. Specific injury counts were not mentioned, but there are reports of the ceramic tip breaking.
Patients and healthcare providers should stop using the resection sheath immediately. Follow the recall instructions provided by Olympus Corporation of the Americas.
For further instructions, contact Olympus Corporation of the Americas. Visit the official recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1445-2026.
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