Olympus Corporation of the Americas recalled 207 units of its Resection Sheath, Model No. A22043T, on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a serious hazard. Patients and healthcare providers 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 Olympus Resection Sheath is a medical device used in urologic applications. It assists healthcare providers during surgical procedures and is valued for its precision.
The ceramic tip of the resection sheath can break, which may result in injury to patients or healthcare providers during usage. This poses a significant safety risk.
This recall is not part of a broader industry pattern.
The recall affects healthcare providers and patients who may have used the device, necessitating immediate action to avoid potential injuries.
The model number and UDI can typically be found on the device packaging or labeling.
Expect a timeline of approximately 4-6 weeks for processing refunds or replacements.
Keep copies of purchase receipts, recall notices, and any correspondence with the manufacturer.
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Distributed nationwide in the U.S. Quantity recalled: 207 units.
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