HIGH

Medline Industries Issues Recall of Catheters Over Infection Risk

Medline Industries recalled 94 lots of Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters on December 22, 2025. The catheters may contain small particles that pose a risk of serious health issues. Users should stop using the devices immediately and follow manufacturer instructions for return.

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

Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters are used in medical settings for diagnostic procedures. They are designed to be reprocessed for multiple uses, making them cost-effective for healthcare providers.

Why This Is Dangerous

The presence of small residual particles in the reprocessed catheters can trigger severe inflammatory responses or infections in patients. These risks can escalate to serious conditions like thrombus reactions or embolisms if the devices are used.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and healthcare providers face potential health risks from using the affected devices. Immediate cessation of use is necessary to prevent serious complications.

Practical Guidance

How to identify if yours is affected

  1. Locate the model number on the catheter packaging or device
  2. Compare the model number against the recalled list
  3. Check for any notifications received from Medline Industries

Where to find product info

Model numbers can typically be found on the packaging or directly printed on the catheter device itself.

What timeline to expect

Expect a refund processing timeline of approximately 4-6 weeks after the return of the device.

If the manufacturer is unresponsive

  • Document all communications with Medline Industries
  • Follow up with customer service
  • Consider filing a complaint with the FDA if issues persist.

How to prevent similar issues

  • Choose single-use catheters when possible to avoid reprocessing risks
  • Verify product safety certifications before purchase
  • Ask healthcare providers about device safety and recall history.

Documentation advice

Keep records of all communications regarding the recall, including emails, letters, and any correspondence with healthcare providers.

Product Details

The recall includes the following model numbers: 10439072RH, 10439236RH, 10438577RH, and 10439011RH. These devices were distributed nationwide in the United States. No specific price was mentioned.

Key Facts

  • Recall date: December 22, 2025
  • Quantity recalled: 94 lots
  • Affected systems: GE and Siemens
  • Risk of serious health issues including embolism
  • Class I recall indicating high risk
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

Product TypeDiagnostic Ultrasound Catheter
Sold At
Multiple Retailers

Product Details

Model Numbers
10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808
10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808
10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808
10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

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