Device recall

Z-1202-2025: Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001…

FDA device recall · Class II · Dexcom, Inc.

Key facts

Recall number (Z-number) Z-1202-2025
Recall event 96091
Product Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Product code QBJ
Recalling firm Dexcom, Inc.
Recall class Class II
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

Browse all FDA device recalls (products)