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.
Take action
Contact the company
📍Recalling firmDexcom, Inc.6340 Sequence Dr · San Diego, CA 92121-4356
“Dexcom G7 CGM App: Missing Sensor Failure Alerts Risk Hyperglycemia.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51741-dexcom-g7-cgm-app-missing-sensor-failure-alerts-risk-hyperglycemia. Based on FDA recall #Z-2446-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2446-2025%22&limit=1).
The FDA announced on July 24, 2025, that Dexcom, Inc. is voluntarily recalling the Dexcom G7 Continuous Glucose Monitoring System and Dexcom ONE+ CGM System apps due to a hazard involving missed glucose alerts. The recall affects app versions 2.8.0 or earlier for Android and iOS/watchOS platforms.
How to tell if you have it
Dexcom G7 CGM Android App, Model SW12299, version 2.8.0 or earlier
Dexcom G7 CGM iOS App, version 2.8.0 or earlier
Dexcom ONE+ CGM Android App, version 1.4.0 or earlier
Dexcom ONE+ CGM iOS App, version 1.4.0 or earlier
The hazard
The affected apps do not provide an expected "Sensor Failed" alert when a transmitter sends a "transmitterFailed" error message during hardware or firmware failure. Instead, the app ends the sensor session and displays a "Start Sensor" screen or "No active sensor" message without alerting the user, which can lead to missed detection of hyperglycemic or hypoglycemic events and delayed treatment.
Context
GovInfoNow's records show Dexcom, Inc. has 9 other recalls on record since July 12, 2019. Other recent recalls include the Dexcom G7 Sensors recall dated May 27, 2026, and the Dexcom G7 CGM App recall dated April 14, 2026. Similar recent recalls of comparable products include the Medtronic InPen App recall on November 13, 2025, and the FreeStyle Libre 3 Plus Sensor recalls on November 24, 2025.
How to tell if you have this one
Check if your Dexcom G7 CGM Android app is version 2.8.0 or earlier. The product code SW12299 with lot code UDI: SW12299 - 00386270001870 indicates the affected model.
Brand
Dexcom
Category
Medical device
FDA recall event · 5 products
All 5 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
Distribution
SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa SW12300 G7 iOS CGM App Worldwide Distribution - US Nationwide and the countries of United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, South Korea, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa SW14245 Dexcom ONE+ Android Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Israel, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden SW14244 D1G7 iOS Mobile App OUS worldwide distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Estonia, Spain, France, United Kingdom, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, Sweden
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used of each are the same for each user. The watchOS app cannot be installed independently from the iOS phone app Component: Dexcom G7 CGM iOS App; Lot Code: UDI - SW1355- 00386270005168
Update the Dexcom G7 Android app to version 2.9.0 or later to fix the sensor failure alerts.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the countries of Andorra, United Arab Emirates, Austria, Australia, Belgium, Bahrain, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2446-2025 (July 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2446-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.