On April 14, 2026, Dexcom began correcting certain versions of its Dexcom G7 and Dexcom ONE+ iPhone apps after finding a software defect that could delay glucose readings and alerts.[1] The FDA posted the recall on May 11, 2026, as a Class 2 recall, and its database listed the recall as open and classified.[1]
What went wrong
The problem sat inside the app's own task scheduling. According to the FDA record, a low-priority file I/O check blocked the higher-priority thread that processes estimated glucose values (EGVs) and trend arrows.[1] An EGV is the glucose number the app shows from the sensor.
When the app ran in the background, EGV notifications could queue up. The record says they then "replay" one after another once the user brought the app to the foreground, so the Glucose Compass flickered through earlier readings before showing the current one.[1] In more severe cases, the app could treat the delay as signal loss and switch on its signal-loss handling.[1]
The FDA record states the risk directly: the delay in EGV and alert processing meant users could miss a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.[1] FDA listed the root cause as software design.[2]
Which apps and how many
The recall event covered three software products:
- Dexcom G7 CGM iOS App (catalog number SW12300), versions 2.9.0 through 2.11.2. FDA listed 58,582 units.[1][2]
- Dexcom G7 CGM watchOS App (SW13355), versions 2.9.0 through 2.11.2. FDA also listed 58,582 units. The record notes that the watch app installs with the iPhone app, runs the same version, and can't be installed on its own.[3][2]
- Dexcom ONE+ iOS CGM App (SW14244), versions 1.5.0 and 1.6.0. FDA listed 70,212 units.[4][2]
The G7 records name both the Dexcom G7 and the Dexcom G7 15 Day systems as components.[1] FDA's distribution entry lists the G7 iOS and watchOS apps as distributed worldwide, including nationwide in the United States. The entry for the ONE iOS app versions 1.5.0 and 1.6.0 lists international distribution only.[2]
What this means for you
Dexcom sent its "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" through the iOS app itself on April 14, 2026.[2] The fix FDA describes is an app update. The notice told customers to tap Update App to reach the app store, install the latest Dexcom ONE+ or Dexcom G7 iOS app version that applies to their product, and then open the app.[2]
The notice said updating from app versions 1.5 to 1.6 was mandatory and that those versions could not be used after April 30, 2026.[2] FDA's record does not name a specific fixed version number. For questions, Dexcom directed customers to find their local Technical Support through Dexcom.com/global.[2] For questions about your glucose readings or your care, talk to your care team or pharmacist.
How to check your lot number
This recall has no physical lot numbers. For these apps, the FDA record's "Lot Code" field lists the app's catalog number and software version range, for example "SW12300 versions 2.9.0 through 2.11.2" for the G7 iPhone app.[1] To see whether your app was affected, compare the version number of the app installed on your iPhone with the ranges in the FDA records: G7 iOS and watchOS versions 2.9.0 through 2.11.2,[1][3] and ONE+ iOS versions 1.5.0 and 1.6.0.[4] The records don't say where in the app the version number is displayed, so Dexcom Technical Support is the place to ask if you can't find it.[2]
We will add a dated update to this post if Dexcom or the FDA changes the scope of the recall or closes it.
References
- U.S. Food and Drug Administration. Class 2 Device Recall Dexcom G7 Continuous Glucose Monitoring System (Z-2163-2026, Dexcom G7 CGM iOS App)Source
- U.S. Food and Drug Administration. openFDA device recall records for recall event 98639 (Z-2163-2026, Z-2164-2026, Z-2165-2026)Source
- U.S. Food and Drug Administration. Class 2 Device Recall Dexcom G7 Continuous Glucose Monitoring System (Z-2164-2026, Dexcom G7 CGM watchOS App)Source
- U.S. Food and Drug Administration. Class 2 Device Recall Dexcom ONE Continuous Glucose Monitoring System (Z-2165-2026, Dexcom ONE+ iOS CGM App)Source