The U.S. Food and Drug Administration (FDA) has issued a warning letter to Medline Industries for violations related to its devices used to inject radiographic contrast media during angiograms.
The company’s NAMIC Angiographic Control Syringes have been linked to air embolism risk; despite receiving 221 complaints and filing 177 medical device reports over the issue, including one confirmed case of air injected into a patient, the company's corrective actions failed to bring complaint rates below established thresholds through three quarters of 2025, the FDA said.
Medline has since initiated a product removal and initiated corrective and preventive actions, according to the letter, dated March 25, 2026.
The FDA warned that failure to adequately address the violations could result in regulatory action including seizure, injunction, or civil money penalties.
