Olympus recalled its Inner Sheath, Model No. A2642, on November 11, 2025, due to safety complaints. Users reported the ceramic tip of the resection sheath breaking during use. This recall affects urological applications and poses a high risk to patients.
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 Inner Sheath, Model No. A2642. It is used for endoscopic diagnosis and treatment in urological applications. The product was distributed nationwide in the US.
The recall stems from complaints regarding the ceramic tip of the resection sheath breaking. This defect poses a high risk of injury during medical procedures.
There have been no specific incident reports or injuries mentioned in the recall data. The severity of the hazard remains high due to the potential for serious complications.
Patients and healthcare providers should stop using the device immediately. Follow the recall instructions provided by Olympus Corporation of the Americas.
For further instructions, contact Olympus Corporation of the Americas or your healthcare provider. More details can be found at the FDA recall link.
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