Medline recalls procedure kits due to catheter safety concerns

July 2, 2026 - 02:37

Medline Industries has initiated a recall of thousands of procedure kits used in cardiac care after discovering a potential safety issue with the included catheters. The recall, classified as Class II by the U.S. Food and Drug Administration, affects kits distributed to cardiologists and cardiac surgeons nationwide.

The problem centers on certain catheters within the kits that may separate or break during use. If a catheter fragment detaches inside a patient's blood vessel, it could travel to the heart or lungs, causing blockages, tissue damage, or other serious complications. Medline reported that the issue was identified through internal testing and customer complaints, though no injuries or deaths have been confirmed as of the recall announcement.

The affected kits include a range of products used for procedures such as angiography, angioplasty, and central line placement. Medline is asking healthcare providers to inspect their inventory and return any kits with the specific lot numbers listed in the recall notice. The company is also working to replace the defective components.

The FDA's Class II designation means the product may cause temporary or reversible health problems, but the risk of serious harm is low. Still, the recall underscores ongoing concerns about medical device quality and supply chain oversight. Hospitals and clinics are advised to check their stock and follow Medline's instructions for handling the affected kits.