Device recall
Z-1324-2026: Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters…
FDA device recall · Class I · Medline Industries, LP
Key facts
| Recall number (Z-number) | Z-1324-2026 |
|---|---|
| Recall event | 98277 |
| Product | Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE Systems 10439072RH; Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on Siemens Systems 10438577RH; Biosense Webster SOUNDSTAR eco… |
| Product code | OWQ |
| Recalling firm | Medline Industries, LP |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K250545 |
| 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