MEDLINE INDUSTRIES, LP - Northfield recalls Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401…

Recall date

February 6, 2025

Source

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

Recall number

Z-1460-2025

FDA classification

Class II

Brand / firm

MEDLINE INDUSTRIES, LP - Northfield

Sold / distributed

US Nationwide distribution in the states of AR, AZ, CA, CO, IA, IL, KS, OR, TN, TX, WA, and WI.

Why it was recalled

Devices may have higher than expected amounts of bacterial endotoxin.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R