What is being recalled?

Specific lots of reprocessed Livewire steerable electrophysiology catheters identified by item numbers are recalled due to residual particulates on patient-contacting surfaces.

Why is this recall being issued?

Residual particulates may trigger inflammation or systemic infection. If particulates detach during use, they could cause embolic events.

Who issued the recall?

Medline Industries, LP and the U.S. Food and Drug Administration.

What should patients do now?

Stop using the devices and follow the recall instructions provided by Medline or your healthcare provider.

Will I get a refund or replacement?

Refund or replacement details are provided by Medline in the recall notice. Contact Medline or your healthcare provider for instructions.

How will I know if my device is affected?

Check the item number on your device against the list above and consult your healthcare provider.

Can these devices still be used safely?

No. The devices in the affected lots should not be used as instructed by the recall.

What if I have already had a procedure using one of the recalled devices?

Contact the healthcare provider who performed the procedure for monitoring and guidance.

Where can I find more information?

Refer to the FDA enforcement report linked in the recall notice and Medline’s recall communications.

HIGHJuly 31, 2025

Medline Livewire Steerable EP Catheters Recalled for Particulates in 2025 (7,913 Units)

Q: Which products are affected?

Items 401575RH, 401582RH, 401600RH, 401603RH, 401606RH, 401652RH, 401653RH, 401654RH, 401904RH, 401905RH, 401908RH, 401914RH, 401915RH, 401918RH, 401932RH, 401933RH, 401934RH, 401938RH, 401939RH, 401940RH.

Medline recalled 7,913 reprocessed Livewire steerable electrophysiology catheters distributed nationwide in the United States. The devices may contain small residual particulates on patient-contacting surfaces, potentially triggering an inflammatory response or systemic infection. Stop using the device and follow recall instructions from Medline or your healthcare provider.

Quick Facts at a Glance

Recall Date: July 31, 2025
Hazard Level: HIGH
Brand: Medline Industries, LP
Category: Health & Personal Care
Sold At: Multiple Retailers
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter

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About This Product

Electrophysiology catheters are used in heart mapping and ablation procedures. Reprocessed catheters are cleaned for reuse but may carry residual contaminants if processing fails. This recall concerns Livewire steerable EP catheters redistributed to U.S. healthcare facilities.

Why This Is Dangerous

Residual particulates on patient-contacting surfaces can cause inflammation or infection. If particulates enter the bloodstream or heart, they may trigger granulomatous reactions, thrombus formation, or embolic events.

Industry Context

This recall is not described as part of a broader industry pattern in the notice.

Real-World Impact

Hospitals may need to stop using the affected devices and replace them, potentially delaying procedures and increasing costs for facilities.

Practical Guidance

How to identify if yours is affected

1. List all device item numbers in your facility inventory.
2. Check packaging and labeling for the listed item numbers.
3. Cross-check against hospital procurement records and supplier catalogs.

Where to find product info

Refer to the recall notice and the FDA enforcement page linked therein for UDI and lot information.

What timeline to expect

Refunds or replacements typically take 4-8 weeks to process.

If the manufacturer is unresponsive

Document all communications with Medline.
Escalate to hospital risk management if supplier does not respond within 2-4 weeks.

How to prevent similar issues

Avoid reprocessed EP catheters if possible; use single-use, sterile-discard catheters.
Verify supplier recalls before device acceptance.
Ensure robust traceability for all lot/UDI codes.

Documentation advice

Keep recall notice, purchase records, packing slips, and all correspondence with Medline as part of your risk management file.

Product Details

Item numbers affected: 401575RH, 401582RH, 401600RH, 401603RH, 401606RH, 401652RH, 401653RH, 401654RH, 401904RH, 401905RH, 401908RH, 401914RH, 401915RH, 401918RH, 401932RH, 401933RH, 401934RH, 401938RH, 401939RH, 401940RH. Where sold: Domestic US distribution nationwide to healthcare facilities. When sold: Unknown. Price: Unknown.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

7,913 units recalled
20 item numbers affected
Class I recall; Hazard Level HIGH
Domestic US nationwide distribution; international distribution pending
Manufacturer: Medline Industries, LP
Remedy: Stop use and follow recall instructions

View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeReprocessed Livewire Steerable Electrophysiology Catheter

Product Details

Feb 27, 2026

Medline Industries, LP

Medline Industries,