Medline Industries Recalls Reprocessed Siemens ACUSON AcuNav Ultrasound Catheters Due to Contamination Risk
According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.
Medline Industries, LP has issued a Class I recall for 511 reprocessed ultrasound catheters that may contain residual material, posing risks of infection or life-threatening embolism.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on February 25, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, MedicalDevices) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
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.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.
What is this FDA recall about? ▾
Which agency issued this alert? ▾
How severe is this alert? ▾
What area is affected? ▾
Where can I find more FDA Recalls updates? ▾
Primary source data
EPA Outdoor Air Quality Data
Federal monitoring network — every measurement we report
AirNow (EPA / NOAA)
Real-time AQI for every monitored U.S. location
National Weather Service
Active watches, warnings, and advisories — NOAA
CDC Air Quality & Health
Health-impact reference behind every AQI category