The FDA has initiated a Class II recall for the Olympus Inner Sheath, Model No. A2660, a device used for endoscopic diagnosis and treatment in urological applications. The recall is prompted by customer complaints indicating that the ceramic tip of the resection sheath has been breaking during use, posing a potential risk to patients.

Healthcare providers and medical device distributors nationwide who have received this product should be aware of this recall. While specific compliance deadlines are not detailed, entities in possession of the affected product should consult the FDA's recall guidelines and contact Olympus Corporation of the Americas for instructions on handling and potential remediation. Failure to comply with recall procedures can result in regulatory action.