Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677… — Class II medical device recall Z-1104-2020
Terminated recall by Dexcom Inc, reported 2020-02-19, distributed nationwide. It was reported that the user's low alarm feature on the iOS application were not properly alerting users when
| Recall number | Z-1104-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dexcom Inc, San Diego, CA, United States |
| Recall initiated | 2019-11-19 |
| Classified | 2020-02-07 |
| Reported by FDA | 2020-02-19 |
| Terminated | 2023-08-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, CH, CZ, DE, DK, ES, FI, GB, HK, IE, IT, LU, NL, NO, SE, ZA |
| Quantity | 237,888 users |
| UPC / GTIN / UDI-DI | 00386270000804 |
Product
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
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.
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-1104-2020. 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.