Medline reprocessed Siemens ACUSON AcuNav ultrasound catheters recalled for residual particles
What this means
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
The agency's original wording
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1325-2026More Medline recalls
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- FDA-Device2026-09-09Medline Convenience Kits recalled for sterility packaging breach risk
- FDA-Device2026-09-09Medline Convenience Kits with BD ChloraPrep Clear applicators recalled for defective packaging seals
- FDA-Device2026-09-09Medline Arterial Line Insertion Kit recalled for sterility packaging breach risk
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