Olympus Corporation of the Americas recalled the Inner Sheath Model No. A2641 on November 11, 2025. The recall follows complaints of the ceramic tip breaking, posing a high risk of injury to patients. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
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. A2641 is designed for use in endoscopic procedures related to urological diagnoses and treatments. Healthcare providers use this device during surgeries to assist in the resection of tissue.
The ceramic tip of the sheath can break during use, which may lead to serious complications or additional surgical interventions for patients. This malfunction poses a significant risk during endoscopic procedures, where precision is critical.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the device immediately to avoid potential injury. This recall may lead to delays in medical procedures requiring the sheath, impacting patient care.
The model number and UDI can typically be found on the device itself, packaging, or accompanying documentation.
Expect processing for refunds or further instructions to take approximately 4-6 weeks.
Keep records of your purchase, any communication with the manufacturer, and photos of the device for reference.
The Olympus Inner Sheath Model No. A2641 is used for endoscopic diagnosis and treatment in urological applications. It has been distributed nationwide in the U.S. The recall affects all lots of this model.
Not sure what to do next? Our guide walks you through the process step by step.
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