Plymouth, MN, United States
Sterilmed, Inc. recalls
3 recalls recorded since 2018, most recently on 8 October 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 8 October 2025
- 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.
- Distribution
- United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0573-2026, Z-0574-2026
- 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 S
- 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 Descripti
Terminated Class II Medical devices
- Recall started
- 17 September 2018
- Terminated
- 4 August 2020
- Reason
- Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, MN, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0090-2019
- Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) medium curl (22.4 mm
Terminated Class I Medical devices
- Recall started
- 2 June 2017
- Terminated
- 29 July 2019
- Reason
- Inadequate seal due to lack of adhesive glue
- Distribution
- US Nationwide distribution in the states of AR, CO, FL, MI, OH, TX, and WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0213-2018
- St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.