Device recall
Z-1197-2025: Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm…
FDA device recall · Class II · Augustine Temperature Management, LLC
Key facts
| Recall number (Z-number) | Z-1197-2025 |
|---|---|
| Recall event | 96155 |
| Product | Hot Dog PATIENT WARMING, Underbody Warming Mattress + Return Electrode, 82 cm (32"), REF US501, to prevent or treat hypothermia |
| Product code | DWJ |
| Recalling firm | Augustine Temperature Management, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K230866 |
| FEI number | 3005857264 |
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