Device recall
Z-2735-2026: Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides…
FDA device recall · Class I · ResMed Ltd.
Key facts
| Recall number (Z-number) | Z-2735-2026 |
|---|---|
| Recall event | 99304 |
| Product | Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation. |
| Product code | CBK |
| Recalling firm | ResMed Ltd. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K152068, K172875 |
| FEI number | 3004604967 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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