Class I U.S. Food and Drug Administration

Medline Industries, LP Reprocessed Livewire Steerable Electrophysiology Catheter Item recall: Specific lots of reprocessed electrophysiology and ultrasound catheters

Recall published 1+ years ago

Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2610-2025
Published
October 8, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
7913 eaches
Distribution
Nationwide
Made in
United States
Lot / code info
Item Number/UDI (ea)/UDI(case): 401575RH 10888277407497 20888277407494; 401582RH 10888277407510 20888277407517; 401600RH 10888277407541 20888277407548; 401603RH 10888277407558 20888277407555; 401606RH 10888277407565 20888277407562; 401652RH 10888277407572 20888277407579; 401653RH 10888277407589 20888277407586; 401654RH 10888277407596 20888277407593; 401904RH 10888277407602 20888277407609; 401905RH 10888277407619 20888277407616; 401908RH 10197344020966 20197344020963; 401914RH 10888277407527 20888177407524; 401915RH 10888277407626 20888277407623; 401918RH 10888277407640 20888277407647; 401932RH 10888277407671 20888277407678; 401933RH 10888277407688 20888277407685; 401934RH 10888277407695 20888277407692; 401938RH 10888277407701 20888277407708; 401939RH 10888277407718 20888277407715; 401940RH 10888277407480 20888277407487; 401941RH 10888277407725 20888277407722; 401991RH 10888277407756 2088277407753; LOTS EP230724 EP230731 EP230803 EP230816 EP230914 EP231017 EP231116 EP240108 EP240122 EP240212 EP240227 EP240311 EP240322 EP240411 EP240415 EP240422 EP240429 EP240507 EP240514 EP240520 EP240528 EP240607 EP240611 EP240710 EP240715 EP240723 EP240805 EP240812 EP240820 EP240829 EP240911 EP240923 EP240930 EP241008 EP241030 EP241125 EP250108
UPC codes
10888277407497, 20888277407494, 10888277407510, 20888277407517, 10888277407541, 20888277407548, 10888277407558, 20888277407555, 10888277407565, 20888277407562, 10888277407572, 20888277407579, 10888277407589, 20888277407586, 10888277407596, 20888277407593, 10888277407602, 20888277407609, 10888277407619, 20888277407616

Products covered by this recall

Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401575RH 401582RH 401600RH 401603RH 401606RH 401652RH 401653RH 401654RH 401904RH 401905RH 401908RH 401914RH 401915RH 401918RH 401932RH 401933RH 401934RH 401938RH 401939RH 401940RH 401941RH 401991RH

Check your product

The notice names 21 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10888277407497
  • 20888277407494
  • 10888277407510
  • 20888277407517
  • 10888277407541
  • 20888277407548
  • 10888277407558
  • 20888277407555
  • 10888277407565
  • 20888277407562
  • 10888277407572
  • 20888277407579
  • 10888277407589
  • 20888277407586
  • 10888277407596
  • 20888277407593
  • 10888277407602
  • 20888277407609
  • 10888277407619
  • 20888277407616

Model or item number

On the rating label, the box or the instruction sheet.

  • UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10888277407497, 20888277407494, 10888277407510; model number UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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