Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product… — Class I medical device recall Z-0318-2026
Ongoing recall by Dexcom, Inc., reported 2025-11-05, distributed nationwide. A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which
| Recall number | Z-0318-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dexcom, Inc., San Diego, CA, United States |
| Recall initiated | 2025-08-28 |
| Classified | 2025-10-30 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 333 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00386270000811 |
| Lot numbers | SW11678 |
| Model numbers | SW11678 |
Product
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
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).
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-0318-2026. 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.