The FDA has initiated a Class II recall for Olympus Resection Sheath, 28 Fr., Model No. A22043A. The reason for the recall is the reported breakage of the ceramic tip of the resection sheath, which poses a risk to patient safety during urologic applications. The product has been distributed nationwide in the US.

This recall requires immediate attention from Olympus Corporation of the Americas and any healthcare providers who may have distributed or used this device. While the document does not specify immediate actions for providers beyond the recall itself, entities involved in the distribution chain should ensure compliance with the recall process. The FDA classifies this as a Class II recall, indicating that use of or exposure to a defective product may cause adverse health consequences that are temporary or medically reversible, or where the probability of serious adverse health consequences is remote.