Olympus Corporation recalled 899 units of the Resection Sheath Model No. A42011A on November 11, 2025. Complaints indicate that the ceramic tip may break during use, posing a high risk to patients. 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 Olympus Resection Sheath Model No. A42011A is designed for use in gynecological procedures to aid in resection. Healthcare providers use this device to ensure safe and effective surgical outcomes.
The breakage of the ceramic tip poses a risk of injury to patients during gynecological procedures. This defect can lead to complications if not addressed immediately.
This recall is not part of a broader industry pattern.
Patients and healthcare providers face significant safety concerns due to the potential for injury. Immediate action is necessary to prevent any possible adverse effects.
The model number and UDI can typically be found on the product packaging or the device itself.
Expect a timeline of 4-6 weeks for refund or replacement processing.
Document all correspondence regarding the recall, including emails and phone call logs. Keep your purchase receipt and any relevant medical records.
The Olympus Resection Sheath Model No. A42011A is used for gynecological applications. The product has a unique device identifier (UDI): 04042761023658. It was distributed nationwide in the U.S.
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