FDA Medical devices recall ·
Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON… recall
- Recall number
- Z-0574-2026
- Date
- (initiated October 8, 2025)
- Company / brand
- Sterilmed, Inc.
5010 Cheshire Pkwy N Ste 2, Plymouth, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4
- Hazard tags
- Sterility Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: GTIN: 10888551004732 LOT# SERIAL#: 2188147 131065 2207154 916179 2220232 1050886 2234795 1170283
Distribution
United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
States: Kentucky Massachusetts Maryland Mississippi New Jersey Pennsylvania Texas Utah
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0574-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.