Dexcom, Inc. medical device recall: Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 97607
- Recall initiated
- Aug 28, 2025
- Classified by FDA
- Oct 30, 2025
- Posted in Enforcement Report
- Nov 5, 2025
- Recalling firm
- Dexcom, Inc.
- Firm location
- San Diego, CA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Aug 28, 2025. FDA classified it 63 days later, on Oct 30, 2025. Distribution reported by FDA: This product was distributed throughout the US. G6 Android US v1.15.0 SW11678 G6 and G6 Pro Android app release has been halted <1% rollout after this issue was identified. Please see the attached consignee data for additional details. Dexcom, Inc. has 11 recalls in our records.
Recalled products (1)
Z-0318-2026 Class I Ongoing
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 Monitoring System
Codes / lots: Lot Code: UDI: SW11678 - 00386270000811
Quantity: 333
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 97607
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.