Device recall
Z-2159-2025: SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
FDA device recall · Class I · Draeger, Inc.
Key facts
| Recall number (Z-number) | Z-2159-2025 |
|---|---|
| Recall event | 97026 |
| Product | SafeStar 55 Plus Filter. Bidirectionally breathing system filter. |
| Product code | CAH |
| Recalling firm | Draeger, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K221836 |
| FEI number | 2517967 |
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