Device recall
Z-1814-2025: Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter…
FDA device recall · Class I · SunMed Holdings, LLC
Key facts
| Recall number (Z-number) | Z-1814-2025 |
|---|---|
| Recall event | 96801 |
| Product | Adult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7 ft Oxygen Tubing, REF CPRM1116F |
| Product code | BTM |
| Recalling firm | SunMed Holdings, LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K953546 |
| FEI number | 1314417 |
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