Sterilmed, Inc. recalls Brand Name: ACUSON
- Recalling company
- Sterilmed, Inc.
- Product
- Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 8, 2025
- Reported
- Nov 26, 2025
- Distribution
- United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
- Status
- Ongoing
- Quantity
- 6
- Lot / codes
- Lot Code: GTIN/UDI: 10888551004725 LOT# SERIAL #: 2196112 999253 2200877 937157 2219499 1182771 2219926 1048031 2220881 1126584 2234882 2304200759
- Company location
- Plymouth, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0573-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0573-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.