Sterilmed, Inc.: Device Recall

Recall #Z-0574-2026 · 10/08/2025

Class II: Risk

Recall Details

Recall Number: Z-0574-2026
Classification: Class II
Product Type: Device
Recalling Firm: Sterilmed, Inc.
Status: Ongoing
Date Initiated: 10/08/2025
Location: Plymouth, MN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4

Reason for Recall

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 Description

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

Distribution Pattern

United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah

Other Recalls by Sterilmed, Inc.

Class II: Risk 10/08/2025

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.

View all recalls by Sterilmed, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.