FDA Warns Medline Syringes

A syringe sounds simple, but in a heart procedure it is the handoff point for contrast dye, the liquid doctors push into blood vessels so they can see blockages on an imaging screen. If that handoff leaks or disconnects, the problem is not a messy table but air or fluid going where it should not. (fiercebiotech.com) That is why the Food and Drug Administration sent Medline a warning letter dated March 25 after inspecting the company’s NAMIC division in Glens Falls, New York, in December 2025. The agency said the plant makes angiographic control syringes and manifolds used to deliver radiographic contrast media during certain heart procedures. (kfgo.com) The defect the agency focused on was disconnection from the manifold, which is the valve-like hub the syringe locks into before dye goes into the patient. The Food and Drug Administration said Medline had linked those disconnections to excess silicone on the device. (fiercebiotech.com) The paper trail did not start last month. The warning letter says complaints began rising in 2023, and Medline later rated the risk as low even though its own hazard analysis listed air embolism, meaning air entering the bloodstream, as the most severe outcome for a loose connection. (fiercebiotech.com) By the Food and Drug Administration’s count, the device generated 221 complaints and 177 safety reports to regulators. The agency said those reports included one case involving air injected into a patient and one case involving biohazard exposure of a clinician. (fiercebiotech.com) Medline had already agreed earlier in 2026 to remove NAMIC angiographic control syringes after discussions with the agency, and a recall plan was put in place in March. A warning letter is the step where the Food and Drug Administration says the fixes on paper are still not good enough and that stronger enforcement can follow. (fiercebiotech.com) (fda.gov) The agency’s concerns also went beyond the syringe itself. Reuters reported that the letter cited weak safety testing and inadequate cleaning practices at the New York facility, which turns a product problem into a manufacturing-system problem. (msn.com) That distinction matters because Medline is not a niche startup selling one gadget. The company is a giant hospital supplier that raised $6.26 billion in its initial public offering in 2025, so a quality issue at one plant can become a regulatory, legal, and commercial problem at the same time. (fiercebiotech.com) The Food and Drug Administration’s public warning-letter page also carries a built-in caveat: the status of issues can change after more interaction with the company. Medline said it is working directly with the agency, but as of April 8 the company was still under a formal warning over devices used in procedures where a loose connection can put air into a bloodstream. (fda.gov) (fiercebiotech.com)