# FDA recall Z-0574-2026

> **Sterilmed, Inc.** · Class II · device recall initiated 2025-10-08.

## 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

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0574-2026
- **Recalling firm:** Sterilmed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-08
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0574-2026

## Citation

> AI Analytics. FDA recall Z-0574-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0574-2026. Source: US FDA. Licensed CC0.

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