FDA warns Medline again over manufacturing quality violations

Medline is under fresh FDA pressure after regulators issued a second warning letter dated May 28, just two months after a March 25 letter that said the company’s NAMIC Division in Glens Falls, New York, had put out cardiovascular procedure kits that did not meet quality-system rules. The March letter followed a December 1-12, 2025 inspection at 10 Glens Falls Tech Park and said NAMIC Angiographic Control Syringes and manifolds were adulterated because the methods, facilities or controls used in manufacturing were not in conformity with FDA requirements.

The agency said Medline’s responses to observations dated January 13 and February 27, 2026 were inadequate and faulted the company for failures in corrective and preventive action, equipment cleaning and maintenance schedules, and device design verification. Regulators traced the complaint history back to June 2023, when reports began building that syringes were disconnecting from manifolds, a problem Medline attributed to excess silicone. FDA cited 221 complaints and 177 medical-device reports, including one case involving air being injected into a patient and another involving biohazard exposure of a clinician.

The safety issue was serious enough to trigger formal product action. FDA recall records show Medline initiated a Class 1 recall on April 10 for kits containing Huons Co. bupivacaine hydrochloride in dextrose injection, and the agency’s recall pages also show a May 26 manifold recall and a May 28 posting for the bupivacaine kits. For hospitals and surgery centers, that means more lot checking and more pressure on purchasing teams to isolate affected inventory in cath labs, anesthesia trays and procedure packs.

Reuters reported that the FDA also told Medline to produce an independent risk assessment of contamination hazards across its manufacturing processes, equipment and facilities, along with a remediation plan and timelines. The repeated warnings suggest a broader quality-control problem rather than a single manufacturing miss, especially after the earlier syringe recall and the separate Medline-related kit recalls posted in May. Medline said it was committed to quality, patient safety and regulatory compliance and was working with the FDA to address the observations. The company, which raised $6.26 billion in its December 2025 IPO by selling 216,034,482 shares at $29 each, is now facing the harder test of proving that its quality systems can keep pace with its scale.