Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND… recallZ-0573-2026 · Sterilmed, Inc. · initiated Oct 8, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sterilmed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Reprocessing Controls
What the company is doing
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.
Recall details
- Recall number
- Z-0573-2026
- Status
- Open, Classified
- Initiated by the company
- Oct 8, 2025
- Posted by the FDA
- Nov 20, 2025
- Recalling firm
- Sterilmed, Inc.
- Quantity
- 6
- Product code
- OWQ
- FDA submissions
- K043453
- Distribution
- United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
Product description
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
Code information (models, lots, serial numbers)
Lot Code: GTIN/UDI: 10888551004725 LOT# SERIAL #: 2196112 999253 2200877 937157 2219499 1182771 2219926 1048031 2220881 1126584 2234882 2304200759
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NA ACU10135910Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall6 reports
Other devices under the same FDA submission
3 devices cleared under K043453 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- NA ACU10135936Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall11 reports
- NA ACU10043342Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter2 reports
- NA R10135936Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 97803).
- Z-0574-2026 · Open, ClassifiedBrand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135936 Sof…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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