Recall Z-0573-2026
Sterilmed, Inc. · initiated October 8, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Code: GTIN/UDI: 10888551004725 LOT# SERIAL #: 2196112 999253 2200877 937157 2219499 1182771 2219926 1048031 2220881 1126584 2234882 2304200759
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.
FDA-determined cause: Reprocessing Controls
Action taken
Initial phone call notification was performed 10/10/2025 to affected customers. Customers were instructed to immediately stop use of identified devices. Affected products should be segregated. Follow-up written notification was sent to customers on 10/17/25 which included instructions on how to return affected products.
Details
- Recall number
- Z-0573-2026
- Initiated
- October 8, 2025
- Posted by FDA
- November 20, 2025
- Product code
- OWQ – Reprocessed Intravascular Ultrasound Catheter
- Quantity
- 6
- Distribution
- United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
- Recalling firm
- Sterilmed, Inc., Plymouth, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0574-2026 Class II | Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV…Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility or… | 10/08/2025Open, Classified |