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Recall Observatory FDA recall evidence

Device product

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

Z-0574-2026

October 08, 2025

Class II

Product summary

Firm
Sterilmed, Inc.
Event
Event 97803
Status
Ongoing
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-0574-2026

Official wording

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.

Code information: Lot Code: GTIN: 10888551004732 LOT# SERIAL#: 2188147 131065 2207154 916179 2220232 1050886 2234795 1170283

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.