Brand Name: ACUSON recall: Sterility Concern
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR…
Why was Brand Name: ACUSON 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: GTIN/UDI: 10888551004725 LOT# SERIAL #: 2196112 999253 2200877 937157 2219499 1182771 2219926 1048031 2220881 1126584 2234882 2304200759
- Product
- Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR…
- Recalling firm
- Sterilmed, Inc.
- Quantity
- 6
- Distribution
- United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
- Recall date
- November 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)