Medline recalls reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters due to potential small particles causing inflammation, infection, or blood clots. Affected units have specific serial numbers and were sold with GE or Siemens systems.
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
Medline is recalling reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters because they may contain small particles that can cause inflammation, infection, or blood clots. This affects specific serial numbers sold with GE or Siemens systems.
The catheters may have small particles of residual material from reprocessing. If used, these particles can cause inflammation, infection, or blood clots that might lead to serious complications like pulmonary embolism or deep vein thrombosis.
Healthcare professionals using these catheters for medical procedures are most at risk. Patients receiving procedures with affected catheters could experience serious complications.
Check for specific serial numbers: 10439072RH, 10438577RH, or 10439011RH with UDI-DI numbers listed in the recall notice. These catheters were sold with GE or Siemens medical systems.
Look for the serial numbers 10439072RH, 10438577RH, or 10439011RH on the catheters.
Reach out to Medline Industries for further assistance if you have the recalled catheters.
Using these reprocessed catheters may cause inflammation, infection, or blood clots that could lead to serious complications like pulmonary embolism or deep vein thrombosis.
These catheters were sold with GE Systems or Siemens Systems.
Check for the serial numbers 10439072RH, 10438577RH, or 10439011RH on the catheters.
We’ve drafted a message you can send Medline to request your refund or repair — edit it as you like.
Subject: Recall Z-1324-2026 — Medline Medline Hello, I own a Medline that is covered by recall Z-1324-2026 from Medline. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
