Z-0574-2026Class II

Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC...

Name: Z-0574-2026 Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC...
Creator: Sterilmed, Inc.
Published: 2025-10-08
License: https://open.fda.gov/license/

Sterilmed Inc / initiated 2025-10-08 / Open, Classified / root cause: sterility

FDA source

Sterilmed, Inc. began a recall of Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM Model/Catalog... on 2025-10-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0574-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-08
Posted: 2025-11-20
Recalling firm: Sterilmed Inc
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
Product code: OWQ Reprocessed Intravascular Ultrasound Catheter
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.
Root cause tag: sterility
FDA root cause: Reprocessing Controls
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.
Quantity in commerce: 4
Distribution: United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
Product codes and lots: Lot Code: GTIN: 10888551004732 LOT# SERIAL#: 2188147 131065 2207154 916179 2220232 1050886 2234795 1170283

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0574-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0573-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-20
Z-0574-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-26	2025-11-20

Product code OWQ

K043453Class IISterilemed Reprocessed Ivus Imaging CatheterSterilmed, Inc. / cleared 2005-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)