Device recall

Z-2163-2026: 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-2163-2026
Recall event 98639
Product Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day…
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

Browse all FDA device recalls (products)