FDA shares details about reprocessed catheter recall

Editor’s Note: This article has been updated to show that the issue in question was linked to a single Class I recall, not seven. While there are seven entries in the FDA Medical Device Recall database, these all live under a single recall event ID. The article was also updated to emphasize that certain steps should be taken before any devices are destroyed.

The U.S. Food and Drug Administration (FDA) is sharing additional information about a Class I recall of certain reprocessed electrophysiology (EP) and ultrasound catheters from Medline Industries. 

"Product lots identified in this communication should be destroyed after recall actions are complete," the agency warned in a new advisory dated March 5. Those actions include reviewing all inventory and filling out the appropriate paperwork, as detailed by the FDA.

Additional context

Back in February, Medline Industries recalled several reprocessed catheters after discovering that they may contain small traces of residual material that could harm a patient. This was an expansion of a recall that was first finalized in July 2025. No serious injuries or deaths have been associated with this issue.

“If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis,” the FDA explained.

The catheters were originally made by a variety of vendors, but Medline Industries reprocessed the devices and then sold them again. Reprocessing single-use devices is a central component of the company's business model, and it estimates this diverts more than 1 million pounds of waste from landfills each year. 

Information about this expanded recall first appeared in the FDA's Medical Device Recall database in February. However, this new advisory is the first time the agency has included the expanded recall on the Medical Device Recalls and Early Alerts section of its website.