Device recall
Z-2164-2026: Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom…
FDA device recall · Class II · Dexcom, Inc.
Key facts
| Recall number (Z-number) | Z-2164-2026 |
|---|---|
| Recall event | 98639 |
| Product | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions… |
| Product code | QBJ |
| Recalling firm | Dexcom, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K240902, K243214 |
| 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