The FDA has initiated a Class II recall for the Olympus Sheath, 10 Fr. (Model No. A37004A), used in urological endoscopic diagnosis and treatment. The recall is prompted by customer complaints indicating that the ceramic tip of the resection sheath has fractured during use. This action is classified as a Class II recall, signifying that use of the device may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.

Healthcare providers and facilities that have distributed or used the affected Olympus Sheath model should immediately cease use and follow the manufacturer's instructions for removal from inventory and return. While the recall is ongoing, specific compliance deadlines for healthcare providers are not detailed in this notice, but prompt action is expected to prevent potential patient harm from device malfunction. The recall impacts nationwide distribution within the US.