CLASS II ONGOING Device recall · Reported 11 Jun 2025 · FDA Enforcement Report
G7 iOS Application recalled by Dexcom
Dexcom is recalling Dexcom G7 iOS Application, distributed nationwide in the US. The recall was initiated on 5 May 2025 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-1906-2025
- FDA event ID
- 96684
- Recalling firm
- Dexcom, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 May 2025
- FDA classified
- 4 Jun 2025
- Reported
- 11 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 5 May 2025 | Recall initiated by company | |
| 4 Jun 2025 | Classified by FDA | +30 days |
| 11 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
Product as listed by the FDA
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
Where it was distributed
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT), Australia (AU), Belgium (BE), Bahrain (BH), Canada (CA), Switzerland (CH), Czech Republic (CZ), Germany (DE), Denmark (DK), Spain (ES), Finland (FI), France (FR), United Kingdom (GB), Hong Kong (HK), Ireland (IE), Israel (IL), Iceland (IS), Italy (IT), Jordan (JO), Korea, Repulic (KR), Kuwait (KW), Lebanon (LB), Lithuania (LT), Luxemburg (LU), Malta (MT), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Poland (PL), Portugal (PT), Qatar (QA), Saudi Arabia (SA), Sweden (SE), Slovenia (SI), Slovakia (SK), Turkey (TR) and South Africa (ZA).
Questions about this recall
Is G7 iOS Application recalled?
Yes. Dexcom recalled G7 iOS Application on 5 May 2025. The recall is Class II and its status is Ongoing. Recall number Z-1906-2025.
Why was it recalled?
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic event or a treatment decision made based off incorrect data. There is no impact to transmitter communication with concurrently connected displays. A concurrently connected receiver, Apple Watch, and/or insulin pump will continue to receive EGVs directly from the transmitter when the app is in the problematic state. There is no impact to Automated Insulin Dosing (AID) therapy as the AID system continues to receive EGVs directly from the transmitter.
Which lots are affected?
Software version 2.7.0/ UDI: 00386270001863
Where was it sold?
Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: United Arab Emirates (AE), Austria (AT), Australia (AU), Belgium (BE), Bahrain (BH), Canada (CA), Switzerland (CH), Czech Republic (CZ), Germany (DE), Denmark (DK), Spain (ES), Finland (FI), France (FR), United Kingdom (GB), Hong Kong (HK), Ireland (IE), Israel (IL), Iceland (IS), Italy (IT), Jordan (JO), Korea, Repulic (KR), Kuwait (KW), Lebanon (LB), Lithuania (LT), Luxemburg (LU), Malta (MT), Netherlands (NL), Norway (NO), New Zealand (NZ), Oman (OM), Poland (PL), Portugal (PT), Qatar (QA), Saudi Arabia (SA), Sweden (SE), Slovenia (SI), Slovakia (SK), Turkey (TR) and South Africa (ZA).
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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