FDA warns Medline over contrast syringe safety issues
The warning letter cites complaint handling, corrective action, and manufacturing-control issues tied to NAMIC angiographic control syringes used with radiographic contrast media.
The U.S. Food and Drug Administration has issued a warning letter to Medline Industries over violations involving NAMIC angiographic control syringes and related cardiovascular procedure kits. The devices are used for intra-arterial or intravenous administration of radiographic contrast media.
FDA said an inspection of Medline’s NAMIC Division facility in Glens Falls, NY, took place from December 1 to 12, 2025. The agency found violations tied to complaint handling, corrective and preventive action, maintenance controls, design controls, and medical device reporting.
The warning letter cited 221 complaints and 177 medical device reports related to syringe disconnection or loose connection issues. The reports included 1 confirmed case involving air injected into a patient and 1 involving biohazard exposure of a clinician.
Air embolism was identified in Medline’s health hazard evaluation as the highest-severity potential harm related to loose connections, according to FDA. The agency said Medline’s corrective actions had not reduced complaint rates below the company’s internal thresholds through 3 quarters of 2025.
Medline issued an urgent medical device recall notice to customers on February 27. The FDA recall record said customers were asked to remove and destroy affected NAMIC RA syringes, with over-labels to be provided for affected kits requiring syringe removal before further use.
The recall was classified as Class I on April 7. FDA said Medline had reported 4 serious injuries and no deaths as of March 13.
Other inspection findings included more than 100 complaints related to foreign matter or hair in device packaging from December 2023 to December 2025. FDA also cited concerns related to maintenance schedules and design-verification activities after component changes.
The agency said failure to adequately address the violations could lead to regulatory action without further notice, including seizure, injunction, or civil money penalties.
Sources
- Medline Industries, LP - 723866 - 03/25/2026. Regulatory filing
- Class 1 Device Recall NAMIC Angiographic Syringe. Regulatory filing
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Radiology Signal Staff covers developments across medical imaging, radiology AI, imaging informatics, clinical research, and radiology business. The team monitors primary sources, peer-reviewed studies, company announcements, society updates, and healthcare industry news to deliver concise reporting for imaging professionals.
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