Device recall
Z-1152-2026: Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B…
FDA device recall · Class II · Edan Diagnostics
Key facts
| Recall number (Z-number) | Z-1152-2026 |
|---|---|
| Recall event | 97879 |
| Product | Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rate and CO2 in a… |
| Product code | DQA |
| Recalling firm | Edan Diagnostics |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K101539 |
| FEI number | 3009499478 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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