Device recall
Z-0318-2026: Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom…
FDA device recall · Class I · Dexcom, Inc.
Key facts
| Recall number (Z-number) | Z-0318-2026 |
|---|---|
| Recall event | 97607 |
| Product | Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose… |
| Product code | QBJ |
| Recalling firm | Dexcom, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K223931 |
| FEI number | 3004753838 |
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