CLASS II Device recall · Reported 19 Feb 2020 · FDA Enforcement Report
G6 CGM App for iOS recalled by Dexcom
Dexcom is recalling G6 CGM App for iOS, distributed nationwide in the US. The recall was initiated on 19 Nov 2019 and the FDA has classified it as Class II.
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-1104-2020
- FDA event ID
- 84436
- Recalling firm
- Dexcom, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2019
- FDA classified
- 7 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Device Malfunction
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 19 Nov 2019 | Recall initiated by company | |
| 7 Feb 2020 | Classified by FDA | +80 days |
| 19 Feb 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application.
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 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
Where it was distributed
US Nation-wide OUS: Austria; Belgium; Canada; Czechia; Denmark; Finland; Germany; Great Britain; Hong Kong; Ireland; Italy; Luxembourg; Netherlands; Norway; South Africa; Spain; Sweden, and Switzerland.
Questions about this recall
Why was it recalled?
It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application.
Which lots are affected?
Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804
Where was it sold?
US Nation-wide OUS: Austria; Belgium; Canada; Czechia; Denmark; Finland; Germany; Great Britain; Hong Kong; Ireland; Italy; Luxembourg; Netherlands; Norway; South Africa; Spain; Sweden, and Switzerland.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 | G6 Continuous Glucose Monitoring System Dexcom G6 recalled | Dexcom | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 465| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |