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Use caution Medical device recall · FDA · Published August 28, 2025

Dexcom G6 App Software Defect May Cause Glucose Missed Alerts

Dexcom recalls G6 and G6 Pro Android apps with software version 1.15.0 that may miss glucose alerts, risking severe diabetic complications. Users should update to fix the issue.

🇺🇸 FDA recall #Z-0318-2026Medical deviceDexcom ›
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Recalling firmDexcom, Inc.6340 Sequence Dr · San Diego, CA 92121-4356
✎ GovInfoNow plain-language explainer

Dexcom is recalling its G6 and G6 Pro Android apps with software version 1.15.0 because a defect can cause the app to crash, potentially missing critical glucose alerts. This could lead to severe hyperglycemia, diabetic ketoacidosis, or hyperosmolar hyperglycemic state if users don't get timely warnings. Read more at govinfonow.com/recall/51535-dexcom-g6-app-software-defect-may-cause-glucose-missed-alerts.

Source Summary by GovInfoNow · govinfonow.com/recall/51535-dexcom-g6-app-software-defect-may-cause-glucose-missed-alerts · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0318-2026

Cite this page

“Dexcom G6 App Software Defect May Cause Glucose Missed Alerts.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51535-dexcom-g6-app-software-defect-may-cause-glucose-missed-alerts. Based on FDA recall #Z-0318-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0318-2026%22&limit=1).

Dexcom, Inc. voluntarily recalled the Dexcom G6 and G6 Pro Android US CGM App (SW11678, version 1.15.0) on Aug. 28, 2025, according to the FDA. A software defect may cause unexpected app termination, preventing users from receiving glucose data or alerts.

How to tell if you have it

  • Brand: Dexcom
  • Product Name: Dexcom G6 and G6 Pro Android US CGM App
  • Model/Catalog Number: SW11678
  • Software Version: version 1.15.0
  • Lot Code: UDI: SW11678 - 00386270000811

The hazard

The software defect can cause the app to terminate unexpectedly, resulting in missed estimated glucose values, alarms, alerts, or notifications. This may lead to the missed detection of hyperglycemic or hypoglycemic events, potentially causing severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).

Context

GovInfoNow's records show Dexcom, Inc. has issued nine other recalls since July 12, 2019. Recent similar recalls include the Dexcom G7 Sensors recall on May 27, 2026, and the Dexcom G7 CGM App hypoglycemia risk recall on April 14, 2026. Other recent recalls of similar products include the Beta Bionics iLet Bionic Pancreas Software recall (March 12, 2026), the Medtronic InPen App recall (Nov. 13, 2025), and the Medtronic CareLink Clinic Software Error recall (Oct. 21, 2025).

How to tell if you have this one

Check if your Dexcom G6 or G6 Pro Android app is version 1.15.0. The product model number is SW11678 with software version 1.15.0.

  • Brand
    Dexcom
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Update the App

    Download the latest app version from Dexcom's official website or app store to fix the software defect.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “This product was distributed throughout the US. G6 Android US v1.15.0 SW11678 G6 and G6 Pro Android app release has been halted <1% rollout after this issue was identified. Please see the attached consignee data for additional details.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Aug 28, 202512. FDA classified it Class I: Oct 30, 202523. Published in FDA’s Enforcement Report: Nov 5, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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-0318-2026 (August 28, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0318-2026 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA