CLASS II ONGOING Device recall · Reported 2 Apr 2025 · FDA Enforcement Report

Medline ReNewal Reprocessed Livewire Steerable recalled

Medline Industries LP - Northfield is recalling Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline, distributed nationwide in the US. The recall was initiated on 6 Feb 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes401582R 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;

Quantity recalled74 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1460-2025
FDA event ID: 96368
Recalling firm: Medline Industries LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 6 Feb 2025
FDA classified: 26 Mar 2025
Reported: 2 Apr 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

6 Feb 2025	Recall initiated by company
26 Mar 2025	Classified by FDA	+48 days
2 Apr 2025	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Devices may have higher than expected amounts of bacterial endotoxin.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Arkansas Arizona California Colorado Iowa Illinois Kansas Oregon Tennessee Texas Washington Wisconsin

Questions about this recall

Why was it recalled?

Devices may have higher than expected amounts of bacterial endotoxin.

Which lots are affected?

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;

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	Medline Industries LP - Northfield	Device Malfunction	6 states
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