Olympus Corporation of the Americas recalled 118 units of its 28 Fr. resection sheath on November 11, 2025. The recall follows reports of the ceramic tip breaking, posing a risk of injury. 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 is a medical device used in urologic applications. It assists in surgical procedures by providing a pathway for instruments.
The hazard arises when the ceramic tip of the resection sheath breaks, which could lead to complications or injuries during procedures.
This recall is not part of a broader industry pattern.
This recall poses a serious concern for healthcare providers and patients, as it requires immediate cessation of use and could disrupt ongoing medical treatments.
The model number can typically be found on the packaging or directly on the product itself.
Expect a refund processing timeline of approximately 4-8 weeks once your request is submitted.
Keep all receipts, correspondence with Olympus, and any documentation regarding the recall for your records.
The recalled product is the Olympus Resection Sheath, Model No. A22043A. It is intended for urologic applications. The devices were distributed nationwide in the U.S.
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