The Recall Desk
HighFDA (Devices)·Z-1460-2025·Announced 2025-04-02

Medline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels

Medline is recalling ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters used in cardiac procedures because the devices may contain higher than expected levels of bacterial endotoxin.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a Class II FDA medical device with potential bacterial endotoxin contamination on an invasive cardiac catheter. No illnesses or injuries have been reported. This meets the criterion of a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries is recalling ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters used in cardiac electrophysiology procedures. The affected devices include model numbers 401582R, 401904R, 401905R, 401933R, and 401991R.

The devices may contain higher than expected amounts of bacterial endotoxin. This contamination led to the recall.

74 units have been distributed nationwide to healthcare facilities in Arkansas, Arizona, California, Colorado, Iowa, Illinois, Kansas, Oregon, Tennessee, Texas, Washington, and Wisconsin. The affected catheters have lot numbers EP240528 and EP240805.

Healthcare facilities with these recalled devices should contact Medline Industries for guidance. Patients who have received procedures with these catheters may contact Medline Industries or the FDA with any questions.

The recalled product

Product
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Cardiac Electrophysiology
Hazard
  • bacterial-endotoxin

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category