Olympus Corporation of the Americas recalled 1,141 units of the Inner Sheath, Model No. WA22017T, on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a high risk to patients. Healthcare providers and patients must stop using the device immediately and follow the manufacturer’s 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. WA22017T, is designed for use in urological and gynecological medical procedures. This device allows for the safe insertion and positioning of instruments during these sensitive applications.
The ceramic tip of the resection sheath can break during use, which may compromise the safety of medical procedures and pose risks to patients. Such breakage could potentially lead to unintended injuries.
This recall is not part of a broader industry pattern.
The recall may cause significant inconvenience for patients and healthcare providers who rely on this device in medical settings. Immediate action is necessary to prevent potential injuries.
The model number and UDI can typically be found on the device packaging or user manual.
Expect a refund or further instructions within 4-6 weeks after contacting the manufacturer.
Keep records of all communications regarding the recall, including emails, letters, and notes from phone calls.
The recalled product is the Olympus Inner Sheath, Long; Model No. WA22017T. It is used for urological and gynecological applications. The product was distributed nationwide in the United States.
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