Device recall
Z-2181-2025: Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult…
FDA device recall · Class I · Ambu Inc.
Key facts
| Recall number (Z-number) | Z-2181-2025 |
|---|---|
| Recall event | 97166 |
| Product | Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 523211000 2 SPUR II Adult Resuscitator w/Mercury Filter, Adult, Catalog Number: 523611051 3 SPUR II Adult Resuscitator, Single Patient Use Resuscitator, Adult, Catalog Number: 523611057 4 SPUR II Adult… |
| Product code | BTM |
| Recalling firm | Ambu Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K152931 |
| FEI number | 1121788 |
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