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 Olympus Inner Sheath, Model No. A2642, is utilized in endoscopic procedures for urological diagnosis and treatment. Healthcare providers use this device to facilitate minimally invasive surgeries.
The ceramic tip of the resection sheath can break during use, posing risks of injury to patients. This defect can compromise the effectiveness of procedures and lead to complications.
This recall is not part of a broader industry pattern.
This recall affects healthcare providers and patients relying on this device for urological procedures. The immediate halt in use may disrupt medical services and patient care.
The model number can typically be found on the device packaging or labeling.
Expect processing of refunds or replacements to take several weeks after the recall notification.
Keep records of your purchase, any correspondence with Olympus, and notes on the recall for your documentation.
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.
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