What should I do if I have used one of the recalled catheters?

If you have used the recalled catheters, stop using them immediately. Contact your healthcare provider for guidance on any necessary medical follow-up.

How can I identify if my catheter is part of this recall?

Check the item numbers listed in the recall announcement. If your catheter matches any of the model numbers provided, it is part of the recall.

Will I get a refund or replacement for my recalled catheter?

Contact Medline Industries for information about refunds or replacements. They will provide specific instructions on how to proceed.

How can I protect myself from future recalls like this?

Stay informed about product recalls related to medical devices by regularly checking the FDA website or subscribing to health alerts.

What are the risks associated with using contaminated catheters?

Using contaminated catheters can lead to inflammatory responses or systemic infections, which may produce serious conditions like embolism.

What is the classification of this recall?

This recall is classified as Class I, indicating the highest risk level for serious health consequences.

Are there any specific symptoms to watch for if I've used a recalled catheter?

Watch for signs of infection such as fever, swelling, or unusual pain. If experienced, seek immediate medical attention.

How long do I have to return the recalled catheters?

You should return the recalled catheters as soon as possible. Follow the instructions provided by Medline for the return process.

What if I no longer have the original packaging?

You can still return the catheter without the original packaging. Just ensure to provide your details and any related information to Medline.

Is my doctor's office aware of this recall?

Most likely, as medical professionals receive alerts on important recalls. However, it's good to confirm with your healthcare provider.

HIGHJuly 31, 2025

Medline Reprocesses 7,913 Electrophysiology Catheters for Safety Risks

Medline Industries recalled 7,913 reprocessed Inquiry Steerable Diagnostics Catheters due to contamination risks. Some models may contain small residual particulates that can cause severe inflammatory responses or systemic infections. Patients must stop using these devices immediately and contact healthcare providers for further instructions.

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

The Inquiry Steerable Diagnostics Catheter is used for electrogram recording and cardiac stimulation during electrophysiologic studies. Medical professionals typically use this device to assess heart conditions and abnormalities, ensuring safe and effective healthcare delivery.

Why This Is Dangerous

Residual particulates on the catheter's patient-contacting surfaces can cause inflammatory reactions if they come into contact with tissues or fluids. Dislodged particles may enter the bloodstream, leading to severe complications such as embolism.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The high hazard level indicates a significant safety concern, warranting immediate action for those who have used the device. Consumers may face health risks that require careful monitoring and professional follow-up.

Practical Guidance

How to identify if yours is affected

Check the item number on your catheter against the recall list.
Verify if your medical provider has been notified of this recall.
If unsure, consult with your healthcare provider to confirm device safety.

Where to find product info

Look for the item number printed on the packaging or the catheter itself. It is often located near the connector.

What timeline to expect

Expect a timeline of 4-6 weeks for processing any return or refund requests.

If the manufacturer is unresponsive

Follow up with the manufacturer through their customer service line.
Consider reaching out your healthcare provider for further assistance.
File a complaint with the FDA if no response is received.

How to prevent similar issues

Research and verify medical devices before use, especially those that have been reprocessed.
Stay updated on recalls to ensure safety compliance.
Always consult healthcare providers regarding the safety of medical devices.

Documentation advice

Keep records of communications regarding the recall, including dates and details of any conversations with Medline or your healthcare provider.

Product Details

- Medline Item Numbers: 81102RH, 81104RH, 81107RH, 81174RH, 81402RH, 81404RH, 81405RH, 81472RH, 81473RH, 81474RH, 81531RH, 81532RH - Recall Date: July 31, 2025 - Report Date: October 8, 2025 - Quantity: 7,913 units distributed nationwide

Reported Incidents

No incidents or injuries have been reported.

Key Facts

7,913 reprocessed catheters recalled
Potential risk of inflammatory response or systemic infection
Hazard classification: Class I
Devices distributed nationwide in the US

View Original Recall on FDA - Medical Devices

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Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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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 TypeElectrophysiology Catheters

Product Details

Feb 27, 2026

Medline Industries, LP

Medline Industries,