The US Food and Drug Administration (FDA) has issued a warning to Medline over deficiencies relating to the company’s angiographic syringe manufacturing protocols.
The warning letter was only just made publicly available and is dated 25 March. Penned by Barbara Marsden, director of the Office of Regulatory Programs and Office of Product Evaluation and Quality at the FDA’s Center for Devices and Radiological Health (CDRH), the document communicates findings from a facility inspection to Medline CEO Jim Boyle.
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Following an inspection of the company’s New York manufacturing facility in December 2025, the letter said that the FDA’s inspecting agent determined that Medline’s NAMIC-branded angiographic control syringes were “adulterated”. This means that good manufacturing practice requirements were not adhered to. The New York facility produces both the syringes and associated kits used to inject radiographic contrast media into patients’ blood vessels for several heart procedures.
Violations identified by the FDA following the inspection included failures by Medline to “establish and maintain” procedures for implementing corrective and preventive action around complaints received about the NAMIC syringes. Medline initiated corrective procedures, attributing syringe connection issues to excess silicone.
The FDA noted that Medline’s declaration of a low risk to health was inconsistent given the potential for air embolisms. A syringe air embolism occurs when air bubbles enter a vessel, potentially blocking blood flow.
“Your firm’s corrective actions only included scrapping devices in inventory and increasing the cleaning frequency of the (b)(4) machine to prevent excess silicone from migrating to the luer connector, despite receiving 221 complaints and filing 177 medical device reports (MDRs) for the disconnection of the NAMIC Angiographic Control Syringes from manifolds which impact patients and clinicians,” the letter continued.
Richard Kalita, senior manager of quality assurance at Medline, responded to the FDA’s observations in two letters dated 13 January and 27 February 2026. However, the agency deemed the company’s planned response to the observed range of issues as inadequate.
“No information was provided on when you anticipate a new investigation will be completed to determine the cause(s) of the disconnections between the syringes and manifolds to assure your actions are timely and commensurate with risk of this issue,” Marsden wrote.
“Furthermore, no assurance was provided that the scope of the product removal will include affected devices manufactured both before and after the corrective action (April 17, 2024) since the corrective action was found to be ineffective,” Marsden continued.
Other remediation issues identified by the FDA include Medline’s “failure to establish and maintain procedures for verifying the device design” and to “establish and maintain schedules for the adjustment, cleaning, and other maintenance of equipment to ensure that manufacturing specifications are met”.
From the date of the letter’s issuance, the FDA concluded that Medline has 15 days to respond to the warning letter. It must provide “specific steps” it intends to take to address the noted violations and inadequate responses outlined in Kalita’s prior correspondence with the agency, as well as an explanation of how the company plans to prevent the same, or similar, violations from occurring again.
The FDA’s warning letter represents the first major hurdle Medline will have to navigate since going public. The company went public on the Nasdaq stock exchange on 17 December 2025, raising $6.26bn in an upsized initial public offering (IPO) that valued the company at $46bn, making it the largest healthcare IPO in history.
