Medline Industries Recalls Reprocessed Siemens ACUSON AcuNav Ultrasound Catheters Due to Contamination Risk

What Happened

Medline Industries, LP has initiated a voluntary Class I recall of specific lots of reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters. The recall was triggered after it was discovered that these devices may contain small particles of residual material. The presence of these particles poses significant health risks, including inflammatory responses, systemic infections, or thrombus reactions that could lead to cerebral or pulmonary embolisms or deep vein thrombosis.

Which Products Are Affected

The recall affects 511 units distributed nationwide across the United States. The following models and lot numbers are included:

• ACUSON AcuNav Ultrasound Catheter (for GE Systems):
  • Model Numbers: 10135910RH, 10043342RH
  • UDI-DI: 10197344026500
  • Lots: EP250324, EP250429, EP250521, EP250609, EP250630, EP250710, EP250905
• ACUSON AcuNav Ultrasound Catheter (for Siemens Systems):
  • Model Numbers: 10135936RH, 08255790RH
  • UDI-DI: 10197344026517
  • Lots: EP250324, EP250429, EP250521, EP250609, EP250630, EP250710, EP250905

What You Should Do

Medline Industries began notifying affected customers via letter on December 22, 2025. Healthcare facilities and providers should immediately check their inventory for the affected model and lot numbers listed above. Affected devices should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information regarding returns or replacements, providers should contact Medline Industries, LP directly.

Why This Matters

This is a Class I recall, the most serious type of recall, indicating that the use of these devices could cause serious health consequences or death. The potential for residual material to cause blood clots or embolisms represents a critical safety failure for these diagnostic tools.

Source

Information provided by the FDA under recall number Z-1325-2026.