Reported Apr 2, 2025 · Ongoing

Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R,…

MEDLINE INDUSTRIES, LP - Northfield

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753

Is this the product you have?

  • Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters
  • Medline Item Numbers
    • 401582R
    • 401904R
    • 401904R
    • 401905R
    • 401933R
    • and 401991R
Lot codes and dates

6 of 6 products

Products covered by this recall
#BarcodesProduct as published
11088827740760220888277407609Lot Number: EP240528; 401904R UDI-DI: 10888277407602 (each) 20888277407609 (case)
21088827740751020888277407609Lot Number: EP240528; 401904R UDI-DI: 10888277407510 (each) 20888277407609 (case)
31088827740751020888277407616Lot Number: EP240805; 401905R UDI-DI: 10888277407510 (each) 20888277407616 (case)
41088827740768820888277407685Lot Number: EP240528; 401933R UDI-DI: 10888277407688 (each) 20888277407685 (case)
51088827740775620888277407753Lot Number: EP240528; 401991R UDI-DI: 10888277407756 (each) 20888277407753 (case)
6Lot Number: EP240528
Amount recalled
74 units

This recall covers 29 products

The agency filed one notice per product. You are reading one of them; the other 28 are below.

16 more are in the archive.

Where it was sold

Why it was recalled

Devices may have higher than expected amounts of bacterial endotoxin.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:21 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.