The U.S. Food and Drug Administration has informed medical device company Medline that some of its syringes used in heart procedures are defective. The agency also warned that the company could face penalties if the problems are not fixed.
The warning letter, issued on March 25, came after an FDA inspection in December 2025 at Medline’s NAMIC facility in Glens Falls. This facility produces syringes and procedure kits that are used to inject contrast dye into patients’ blood vessels during cardiovascular treatments.
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The U.S. Food and Drug Administration said Medline did not take proper action after receiving complaints in June 2023 about NAMIC syringes disconnecting from manifolds. The company had linked this issue to excess silicone on the connectors.
The FDA also warned that if these problems are not fixed, it could take serious action, including seizing products, taking the company to court, or imposing financial penalties.
A Medline spokesperson responded on Wednesday that the company takes “these matters seriously, are working directly with the FDA to address the observations and have initiated actions to strengthen our processes where needed.”
Medline received 221 complaints and submitted 177 safety reports to regulators. These included one case of Air Embolism, a potentially life-threatening condition caused by air entering the bloodstream, and another incident where a clinician was exposed to a biohazard.
The U.S. Food and Drug Administration said Medline’s internal risk analysis identified Air Embolism as the most serious potential failure. However, the company still classified the overall risk as low—an assessment the FDA said did not align with its own findings.
The U.S. Food and Drug Administration said Medline’s attempted fixes did not resolve the issue, with complaint rates continuing to rise throughout 2025 and exceeding the company’s safety limits every quarter.
The company later recalled the syringes and submitted a product removal report in March 2026.
The FDA also flagged Medline for poor cleaning practices at its manufacturing facility, along with inadequate safety testing after making design changes.
