The U.S. Food and Drug Administration has issued a warning letter to Medline Inc. (NASDAQ:MDLN), following an inspection that identified significant quality system violations tied to its cardiovascular device kits, raising concerns about patient safety and regulatory compliance.

FDA Flags Manufacturing And Quality System Failures

The inspection, conducted between December 1 and December 12, 2025, at Medline's New York facility, found that the company's angiographic control syringes and related components failed to meet current good manufacturing practice standards.

The FDA determined the devices were "adulterated" under federal law due to deficiencies in manufacturing controls, quality systems, and compliance with established regulations.

CAPA Process Breakdown Raises Safety Concerns

The letter dated March 25 highlighted Medline's failure to properly implement corrective and preventive action (CAPA) procedures.

Despite 221 complaints and 177 medical device reports tied to syringe disconnections, the company's corrective actions—such as scrapping inventory and increasing cleaning frequency—were deemed insufficient relative ...