Medline Industries Recalls Reprocessed Siemens ACUSON AcuNav Ultrasound Catheters Due to Contamination Risk
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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 April 6, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
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 ↗
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