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

Stop using the ultrasound catheter immediately. Contact your healthcare provider or Medline Industries for further instructions.

How can I identify if my ultrasound catheter is affected?

Check the model numbers: 10135910RH and 10135936RH. If you have one of these models, it may be affected.

What are the risks associated with using these catheters?

Using the affected catheters can lead to serious health risks, including systemic infections and embolisms.

Will I get a refund for the recalled product?

Yes, contact Medline Industries for instructions on returning the product and obtaining a refund.

Is there a deadline for returning the recalled catheters?

While a specific deadline was not mentioned, it is important to act quickly to ensure safety.

What happens if I used the affected catheter?

If you have used the affected catheter and experience any adverse effects, seek medical attention immediately.

Where can I find more information on the recall?

Visit the FDA website or contact Medline Industries for detailed information on the recall.

Are there any reported injuries from this recall?

As of now, there have been no reported injuries or deaths associated with this recall.

What is the classification of this recall?

This recall is classified as Class I, indicating a high risk of serious health consequences.

Can I still use ultrasound catheters from other manufacturers?

It is best to consult your healthcare provider regarding the use of ultrasound catheters from other manufacturers. Ensure they are not part of any recall.

HIGHDecember 22, 2025

Medline Industries Recalls Ultrasound Catheters Over Infection Risk

Medline Industries recalled 511 reprocessed AcuNav ultrasound catheters on December 22, 2025. These devices may contain small particles that can cause serious health risks such as systemic infections and embolisms. Healthcare providers must stop using the affected devices immediately to prevent potentially life-threatening complications.

Quick Facts at a Glance

Recall Date: December 22, 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

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

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 ACUSON AcuNav Diagnostic Ultrasound Catheters are used in medical imaging to provide real-time visualization of internal structures. Healthcare providers rely on these devices for accurate diagnoses during procedures.

Why This Is Dangerous

The risk arises from small particles of residual material within the catheters, which can lead to serious health complications if introduced into the body during use.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers and healthcare providers must act immediately to prevent potential health risks associated with the use of these catheters.

Practical Guidance

How to identify if yours is affected

Check the model number on the catheter packaging.
Verify if the catheter is among the recalled models: 10135910RH or 10135936RH.
Look for any notifications from healthcare providers regarding the recall.

Where to find product info

Model numbers are typically found on the product packaging or the catheter itself.

What timeline to expect

Expect a refund or replacement processing timeline of approximately 4-6 weeks after returning the product.

If the manufacturer is unresponsive

Document all communications with the company.
Consider reaching out to the FDA for further guidance.
File a complaint if you do not receive a response.

How to prevent similar issues

Always check for recalls before purchasing medical devices.
Look for single-use products to minimize infection risks.
Ensure devices are from reputable manufacturers.

Documentation advice

Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.

Product Details

The recall involves the ACUSON AcuNav Ultrasound Catheter models 10135910RH and 10135936RH. These catheters were distributed nationwide in the United States.

Key Facts

511 units recalled
High hazard level
Risk of serious infections
Use on GE and Siemens systems
Follow manufacturer's recall instructions

View Original Recall on FDA - Medical Devices

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Safety Guide

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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 TypeDiagnostic Ultrasound Catheter

Product Details

Brand

Medline Industries, LP

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