Dexcom G7 iOS Application — Class II medical device recall Z-1906-2025
Ongoing recall by Dexcom, Inc., reported 2025-06-11, distributed nationwide. 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 es
| Recall number | Z-1906-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dexcom, Inc., San Diego, CA, United States |
| Recall initiated | 2025-05-05 |
| Classified | 2025-06-04 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IS, IT, JO, KR, KW, LB, LT, MT, NL, NO, NZ, OM, PL, PT, QA, SA, SE, SI, SK, TR, ZA |
| Quantity | 61,355 users |
| UPC / GTIN / UDI-DI | 00386270001863 |
| Model numbers | SW12300 |
Product
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1906-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.