Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR U
FDA device recall Z-0574-2026 · posted 2025-11-20 · Open, Classified
Recall details
- Recalling firm
- Sterilmed, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Reprocessing Controls
- Status
- Open, Classified
- Product code
- OWQ
- Quantity affected
- 4
- Distribution
- United States Only: Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, Pennsylvania, Texas, Utah
- Date initiated
- 2025-10-08
- Date posted
- 2025-11-20
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STERILEMED REPROCESSED IVUS IMAGING CATHETER (K043453) | Sterilmed, Inc. | 2005-03-01 |