Device recall
Z-0574-2026: Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON…
FDA device recall · Class II · Sterilmed, Inc.
Key facts
| Recall number (Z-number) | Z-0574-2026 |
|---|---|
| Recall event | 97803 |
| 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… |
| Product code | OWQ |
| Recalling firm | Sterilmed, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K043453 |
| FEI number | 3011276773 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database