Device recall
Z-2165-2026: Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name…
FDA device recall · Class II · Dexcom, Inc.
Key facts
| Recall number (Z-number) | Z-2165-2026 |
|---|---|
| Recall event | 98639 |
| Product | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System |
| Product code | QBJ |
| Recalling firm | Dexcom, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3004753838 |
At a glance
- None 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