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
401582R401904R401904R401905R401933Rand 401991R
- Lot codes and dates
6 of 6 products
Products covered by this recall # Barcodes Product as published 1 1088827740760220888277407609Lot Number: EP240528; 401904R UDI-DI: 10888277407602 (each) 20888277407609 (case) 2 1088827740751020888277407609Lot Number: EP240528; 401904R UDI-DI: 10888277407510 (each) 20888277407609 (case) 3 1088827740751020888277407616Lot Number: EP240805; 401905R UDI-DI: 10888277407510 (each) 20888277407616 (case) 4 1088827740768820888277407685Lot Number: EP240528; 401933R UDI-DI: 10888277407688 (each) 20888277407685 (case) 5 1088827740775620888277407753Lot Number: EP240528; 401991R UDI-DI: 10888277407756 (each) 20888277407753 (case) 6 Lot 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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