Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0573-2026 — 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 UL

U.S. FDA — Device Enforcement · United States · 2025-10-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0573-2026
Date of alert: 2025-10-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Sterilmed, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10888551004725

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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