Device recall
Z-3253-2026: nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT…
FDA device recall · Class II · Criticare Technologies, Inc.
Key facts
| Recall number (Z-number) | Z-3253-2026 |
|---|---|
| Recall event | 99545 |
| Product | nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-ST, CAT 8100EP1-ST-US, CAT 8100EP1-US, CAT 8100EP1R |
| Product code | MHX |
| Recalling firm | Criticare Technologies, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K030613 |
| FEI number | 3012238587 |
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