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Open, Classified

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

FDA Recall Z-0574-2026 · Posted 2025-11-20

Recalling FirmSterilmed, Inc.
Recall StatusOpen, Classified
Product CodeOWQ
Date Initiated2025-10-08
Product Quantity4

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.

Firm Action

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.

Root Cause

Reprocessing Controls

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043453STERILEMED REPROCESSED IVUS IMAGING CATHETERSterilmed, Inc. · 2005-03-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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