Device recall
Z-1325-2026: Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav…
FDA device recall · Class I · Medline Industries, LP
Key facts
| Recall number (Z-number) | Z-1325-2026 |
|---|---|
| Recall event | 98277 |
| Product | Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH |
| Product code | OWQ |
| Recalling firm | Medline Industries, LP |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K234064 |
| FEI number | 1417592 |
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