Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product… — Class I medical device recall Z-2449-2025
Ongoing recall by Dexcom, Inc., reported 2025-09-10, distributed nationwide. The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS an
| Recall number | Z-2449-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dexcom, Inc., San Diego, CA, United States |
| Recall initiated | 2025-07-24 |
| Classified | 2025-09-04 |
| Reported by FDA | 2025-09-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, CA, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HK, HR, IE, IL, IS, IT, JO, JP, KR, KW, LB, LT, LU, LV, MT, NL, NO, NZ, OM, PL, PT, QA, RO, SA, SE, SI, SK, TR, ZA |
| Quantity | 41,629 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00386270004314 |
| Lot numbers | SW14245 |
| Model numbers | SW14245 |
Product
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM App Model/Catalog Number: SW14245 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ Androind CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System
Reason for recall
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App . The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
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-2449-2025. 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.