CLASS I ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
G6 Continuous Glucose Monitoring System Dexcom G6 recalled
Dexcom is recalling G6 Continuous Glucose Monitoring System Dexcom G6 and G6 Pro Android US CGM App, distributed nationwide in the US. The recall was initiated on 28 Aug 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0318-2026
- FDA event ID
- 97607
- Recalling firm
- Dexcom, San Diego, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 28 Aug 2025
- FDA classified
- 30 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 28 Aug 2025 | Recall initiated by company | |
| 30 Oct 2025 | Classified by FDA | +63 days |
| 5 Nov 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
Lot Code: UDI: SW11678 - 00386270000811
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Dexcom
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 US Retail recalled | Dexcom | Device Malfunction | CA |
| Device | CLASS II | ONE+ iOS CGM App recalled by Dexcom | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalled | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 CGM watchOS App recalled | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS I | G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalled | Dexcom | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 466| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |