Olympus recalled 94 units of its 10 Fr. endoscopic sheath on November 11, 2025, due to complaints of the ceramic tip breaking. The defect poses a high risk for patients undergoing urological procedures. 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 Sheath, Model No. A37004A, is used for endoscopic diagnosis and treatment in urological procedures. It is essential for medical professionals performing such procedures.
The ceramic tip of the sheath can break, which may cause complications during endoscopic procedures. This defect poses a danger to patients and requires immediate attention.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must act promptly to avoid potential injuries related to this device. The recall creates an urgent need for safe alternatives in medical procedures.
The model number and UDI can typically be found printed on the packaging or the device itself.
Expect a response from Olympus within 4-6 weeks regarding refunds or replacements.
Keep records of your product details, recall notices, and any correspondence with the manufacturer.
The affected product is the Olympus Sheath, model number A37004A, with UDI 04042761023092. The sheath is designed for endoscopic diagnosis and treatment in urological applications and was distributed nationwide in the U.S.
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