Recall database

Sterilmed, Inc. recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-0574-2026

Sterilmed, Inc. recalls Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON

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…

Reprocessed Intravascular Ultrasound Catheter
Reprocessing Controls

Sterilmed, Inc.MNNov 26, 2025

Class IIOngoingZ-0573-2026

Sterilmed, Inc. recalls Brand Name: ACUSON

Reprocessed Intravascular Ultrasound Catheter
Reprocessing Controls

Sterilmed, Inc.MNNov 26, 2025