Home / Recalls / Medical Devices
Sterilmed, Inc. recalls Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR
Recalled November 26, 2025 · FDA recall Z-0574-2026 · Sterilmed
Hazard
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. · FDA Class II
Units
4
Sold at
United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
Description
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.
Product
Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Component: N/A
Manufacturer(s)
Sterilmed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →