FDA recall Z-1460-2025

MEDLINE INDUSTRIES, LP - Northfield · Class II · device

Product

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

Reason for recall

Devices may have higher than expected amounts of bacterial endotoxin.

Distribution

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

Key facts

Status: Ongoing
Initiation date: 2025-02-06
Report date: 2025-04-02
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1460-2025