Home / Recalls / Sterilmed, Inc. / Z-0573-2026

Z-0573-2026 Class II Ongoing

Recalled by Sterilmed, Inc. — Plymouth, MN

Recall Details

Product Type
Devices
Report Date
November 26, 2025
Initiation Date
October 8, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6

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

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 Pattern

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

Code Information

Lot Code: GTIN/UDI: 10888551004725 LOT# SERIAL #: 2196112 999253 2200877 937157 2219499 1182771 2219926 1048031 2220881 1126584 2234882 2304200759

Other recalls by Sterilmed, Inc.

  • Z-0574-2026 Class II — Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHET (October 8, 2025)
  • Z-0090-2019 Class II — Reprocessed Agilis Steerable Introducer: indicated for introducing various card (September 17, 2018)
  • Z-0213-2018 Class I — St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 2 (June 2, 2017)
  • Z-2669-2017 Class II — Electrophysiology catheter cables are designed as electrode cables with a multi (May 8, 2017)
  • Z-1846-2016 Class II — Reprocessed Microline Scissor Tips intended to be used with a reusable hand piec (April 26, 2016)
  • Z-0404-2016 Class II — Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed (November 13, 2015)
  • Z-2819-2015 Class II — Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (August 24, 2015)
  • Z-0059-2015 Class II — Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, C (September 24, 2014)