Skip to content
Get alerts
GovInfoNow
Use caution Medical device recall · FDA · Published April 14, 2026

Dexcom G7 CGM App: Hypoglycemia Risk Due to Glucose Data Delays

Dexcom recalls G7 CGM watchOS app versions 2.9.0-2.11.2 for potential glucose data delays that could cause missed hypoglycemic events. Affected users should check their app version and contact Dexcom.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2164-2026Medical deviceDexcom ›
Take action

Contact the company

Recalling firmDexcom, Inc.6340 Sequence Dr · San Diego, CA 92121-4356
✎ GovInfoNow plain-language explainer

Dexcom is recalling its G7 CGM watchOS app versions 2.9.0 through 2.11.2 because software issues may delay glucose readings, risking missed hypoglycemic or hyperglycemic events. This could lead to dangerous blood sugar levels if users rely on outdated information. Read more at govinfonow.com/recall/49467-dexcom-g7-cgm-app-hypoglycemia-risk-due-to-glucose-data.

Source Summary by GovInfoNow · govinfonow.com/recall/49467-dexcom-g7-cgm-app-hypoglycemia-risk-due-to-glucose-data · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2164-2026

Cite this page

“Dexcom G7 CGM App: Hypoglycemia Risk Due to Glucose Data Delays.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49467-dexcom-g7-cgm-app-hypoglycemia-risk-due-to-glucose-data. Based on FDA recall #Z-2164-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2164-2026%22&limit=1).

The FDA announced on April 14, 2026, that Dexcom, Inc. is voluntarily recalling the Dexcom G7 CGM watchOS App due to a software defect that may cause delayed glucose readings and missed alerts. The recall affects SW13355 versions 2.9.0 through 2.11.2 distributed worldwide.

How to tell if you have it

  • Brand: Dexcom
  • Product Name: Dexcom G7 CGM watchOS App
  • Model/Catalog Number: SW13355
  • Software Version: Versions 2.9.0 through 2.11.2
  • Lot Code: SW13355 versions 2.9.0 through 2.11.2
  • UDI-DI: 00386270005168

The hazard

According to the FDA, a software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows may cause EGV notifications to queue up and replay sequentially. This delay creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

Context

GovInfoNow's records show Dexcom, Inc. has 9 other recalls on record since July 12, 2019. Other recent recalls of similar products include the Dexcom G7 Sensors Recall dated May 27, 2026, and the Dexcom G6 App Software Defect recall dated August 28, 2025. Additional related recalls include the Beta Bionics iLet Bionic Pancreas Software recall on March 12, 2026, the Medtronic CareLink Clinic Software Error recall on October 21, 2025, and the Abbott Diabetes Care FreeStyle Libre 3 Sensor Recall on November 24, 2025.

How to tell if you have this one

Check if your Dexcom G7 CGM watchOS app is version 2.9.0 through 2.11.2. The app is installed with the iOS phone app and cannot be used alone.

  • Brand
    Dexcom
  • Category
    Medical device
FDA recall event · 3 products

All 3 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 II
  • Status
    Ongoing
  • Distribution
    SW12300 & SW13355 Dexcom G7 iOS and watchOS app versions 2.9.0 through 2.11.2: Worldwide - US Nationwide including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Austria, Australia, Belgium, Bahrain, Canada, Czech Republic, Germany, Denmark, Estonia, Finland, France, Hong Kong, Ireland, Israel, Iceland, Italy, Jordan, Japan, Kuwait, Luxembourg, Malta, Netherlands, Norway, New Zealand, Oman, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom. SW14245 Dexcom ONE iOS App versions 1.5.0 and 1.6.0 - Only International distribution to the countries of Andorra, Australia, Belgium, Bulgaria, Czech Republic, Estonia, France, Greece, Croatia, Ireland, Italy, Lithuania, Latvia, Malaysia, Monaco, Netherlands, New Zealand, Poland, Qatar, Romania, Saudi Arabia, Spain, Sweden, United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-2163-2026Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System; Lot Code: SW12300 versions 2.9.0 through 2.11.2 - UDI-DI: 0038627000186358582
Z-2164-2026Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System; Lot Code: SW13355 versions 2.9.0 through 2.11.2 - UDI-DI: 0038627000516858582
Z-2165-2026Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System; Lot Code: SW14244 versions 1.5.0 and 1.6.0 - UDI-DI: 0038627000430770212
Based on the official FDA remedy

What to do — step by step

  1. Check App Version

    Open your watchOS app settings to see the version number. Versions 2.9.0 through 2.11.2 are affected.

  2. Update App

    Update to the latest version of the Dexcom G7 CGM watchOS app through the Apple App Store.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “SW12300 & SW13355 Dexcom G7 iOS and watchOS app versions 2.9.0 through 2.11.2: Worldwide - US Nationwide including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 36 days after the firm started it.

1. Firm started the recall: Apr 14, 202612. FDA classified it Class II: May 11, 202623. Published in FDA’s Enforcement Report: May 20, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

Similar recalls

Dexcom G7 CGM App: Missing Sensor Failure Alerts Risk Hyperglycemia
DexcomDexcom G6 App Software Defect May Cause Glucose Missed Alerts
DexcomDexcom One+ Glucose Monitor: Risk of missed alerts causing health emergencies
DexcomDexcom G7 Sensors Recalled: Risk of Skin Infection and Inaccurate Readings
DexcomBeta Bionics iLet Bionic Pancreas Software 1.4.2/1.4.3 Recall: Delayed Glucose Readings
Beta Bionics

Latest medical device recalls

Safeguard US Operating LLC recalls Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced,
Safeguard US · September 2, 2026Medtronic MiniMed, Inc. recalls Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product
MiniMed · August 20, 2026Medline Industries, LP recalls Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical
Medline · August 14, 2026CooperVision, Inc. recalls Brand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog Number: Pearle Vision 1 day
CooperVision · August 12, 2026Tandem Diabetes Care, Inc. recalls Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS
Tandem Diabetes Care · July 16, 2026BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026

Keep exploring

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-2164-2026 (April 14, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2164-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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