The FDA issued a warning letter to Medline over issues with its Namic brand angiographic control syringes and manifolds used for radiographic contrast media administration. The agency identified multiple problems and warned that failure to promptly correct the violations could trigger enforcement actions including seizure, injunctions and civil money penalties. The regulatory step highlights how med-tech quality systems and process controls remain a focus of FDA oversight, particularly for devices integrated into high-stakes clinical pathways such as angiography. For suppliers and hospital procurement teams, the practical concern is potential disruption risk if the company escalates controls, recalls, or faces further regulatory steps after the warning.