Medline Industries, LP recalls Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numb…

Recall date

July 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2611-2025

FDA classification

Class I

Brand / firm

Medline Industries, LP

Sold / distributed

Domestic US distribution nationwide. International distribution pending. No international distribution.

Why it was recalled

Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. 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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mapping of cardiac structures. Medline Item Numbers BD710DF282CRH BD710DF282RRH BD710FJ282CRH BD710FJ282RRH