FDA-Device2026-02-18Class IPROCESSING DEFECT

Medline reprocessed Siemens ACUSON AcuNav ultrasound catheters recalled for residual particles

OTHERNationwide distribution

Stop using affected ACUSON AcuNav catheters immediately

Medline Industries is recalling certain lots of reprocessed Siemens ACUSON AcuNav ultrasound catheters because they may contain small particles of leftover material from reprocessing. If used, these particles could cause inflammation, infection, or blood clots that may lead to serious complications including stroke or pulmonary embolism.

  • Check if your facility has any of the affected catheter lots: EP250324, EP250429, EP250521, EP250609, EP250630, EP250710, or EP250905
  • Stop using affected catheters immediately and quarantine them
  • Contact Medline Industries for replacement or return instructions
  • Notify your healthcare team and patients who may have received procedures with affected catheters
Hazard

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

Sold states
Distribution US nationwide.
Affected count
511
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1325-2026

More Medline Industries, LP recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief