MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2025 - (Recall #: Z-1460-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 6, 2025

Date Posted: April 2, 2025

Recall Number: Z-1460-2025

Event ID: 96368

Reason for Recall:

Devices may have higher than expected amounts of bacterial endotoxin.

Status: Ongoing

Product Quantity: 74 units

Code Information:

401582R UDI-DI: 10888277407510 (each) 20888277407517 (case), Lot Number: EP240528; 401904R UDI-DI: 10888277407602 (each) 20888277407609 (case), Lot Number: EP240528; 401904R UDI-DI: 10888277407510 (each) 20888277407609 (case), Lot Number: EP240805; 401905R UDI-DI: 10888277407510 (each) 20888277407616 (case), Lot Number: EP240528; 401933R UDI-DI: 10888277407688 (each) 20888277407685 (case), Lot Number: EP240528; 401991R UDI-DI: 10888277407756 (each) 20888277407753 (case), Lot Number: EP240528;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated