Medline Industries Recalls Reprocessed Biosense Webster Ultrasound Catheters Due to Potential Contamination

What Happened

Medline Industries, LP has initiated a voluntary recall of specific lots of reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters. The FDA has classified this as a Class I recall, indicating a high level of severity. The recall was prompted by the discovery that these reprocessed devices may contain small particles of residual material. If used, these particles could trigger serious adverse health events.

Which Products Are Affected

The recall involves 94 units distributed nationwide across the United States. Affected products include:

• Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems: Model 10439072RH (UDI-DI 10197344157297)
• Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems: Model 10438577RH (UDI-DI 10197344157273)
• Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter, Use on Siemens Systems: Model 10439011RH (UDI-DI 10197344157280)
• Additional Model: 10439236RH (UDI-DI 10197344157303)

Affected Lot Numbers: EP250724 and EP250808.

What You Should Do

Medline Industries notified affected customers via letter starting on December 22, 2025. Healthcare facilities and providers should immediately check their inventory for the affected lot numbers (EP250724 and EP250808). Any affected devices should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information regarding returns or specific procedures, facilities should contact Medline Industries, LP directly.

Why This Matters

The presence of residual material in these catheters poses a significant health risk to patients. Potential complications include inflammatory responses, systemic infections, granulomatous reactions, or thrombus reactions. These conditions may lead to life-threatening events such as cerebral or pulmonary embolisms or deep vein thrombosis.

Source

FDA Recall Z-1324-2026