Food, drugs, devices › Dexcom, Inc.
Device recall: Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001
Dexcom, Inc. (San Diego, CA) initiated this device recall on 27 Jan 2025; FDA lists 3 product records under event 96091, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Dexcom, Inc. has 11 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Dexcom, Inc., San Diego, CA.
Reason for recall
"Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert…"
Distribution
"Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1202-2025 | Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 | N/A | Class II | Ongoing | 26 Feb 2025 |
| Z-1203-2025 | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 | N/A | Class II | Ongoing | 26 Feb 2025 |
| Z-1204-2025 | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 | N/A | Class II | Ongoing | 26 Feb 2025 |
Context
Other enforcement events for Dexcom, Inc.
All 11 events for Dexcom, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.