Medline Class 1 Recall of Angiographic Control Syringes

Medline Industries has recalled (Class 1) its angiographic control syringes, warning the devices could cause severe injury or death. The recall affects Namic Angiographic Rotating Adaptor Control Syringes and related convenience kits, which are used to deliver contrast media during imaging procedures. The company has instructed customers to immediately remove and destroy all affected syringes and quarantine existing inventory.

According to an FDA recall notice, the devices may malfunction if the rotating adaptor unwinds during use, potentially causing a loose connection or complete disconnection between the syringe and the manifold. Such failures could lead to blood loss, infection, or the introduction of air into the system, raising the risk of a potentially life-threatening air embolism.

As of mid-March, Medline has reported four serious injuries linked to the defect, with no deaths confirmed.