Reported Nov 26, 2025 · Ongoing
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER…
Sterilmed, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sterilmed, Inc. · 5010 Cheshire Pkwy N Ste 2 · Plymouth, MN · 55446-4101
Is this the product you have?
- Brand NameACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR
- USE WITH SIEMENS SYSTEM Product NameCATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH
- SIEMENS SYSTEM Model/Catalog NumberACU10135910
- Software VersionN/A
- Product DescriptionACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT
- FOR USE WITH SIEMENS SYSTEM ComponentN/A
- Lot codes and dates
- Lot CodeGTIN/UDI: 10888551004725 LOT# SERIAL #:
2196112999253220087793715722194991182771221992610480312220881112658422348822304200759
- Lot CodeGTIN/UDI: 10888551004725 LOT# SERIAL #:
- Amount recalled
- 6
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead to severe adverse events such as infection, vascular injury or embolism.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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