Recall Z-0574-2026— Sterilmed, Inc.

Name: FDA recall Z-0574-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-08

Class II · Ongoing

Class II FDA medical device recall by Sterilmed, Inc., initiated 2025-10-08. It names one FDA 510(k) clearance: K043453. 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: 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..

Recalling firm: Sterilmed, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-10-08
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K043453 — STERILEMED REPROCESSED IVUS IMAGING CATHETERSterilmed, Inc.·cleared 2005-03-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.