Z-2165-2026Class II

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App...

Name: Z-2165-2026 Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App...
Creator: Dexcom, Inc.
Published: 2026-04-14
License: https://open.fda.gov/license/

Dexcom, Inc. / initiated 2026-04-14 / Open, Classified / root cause: software

FDA source

Dexcom, Inc. began a recall of Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions... on 2026-04-14. FDA classified it as Class II and gives the reason as "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. When the app is running in the background, EGV...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2165-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-14
Posted: 2026-05-11
Recalling firm: Dexcom, Inc.
Product: Brand 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
Product code: QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Reason for recall: 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. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Root cause tag: software
FDA root cause: Software design
Action: On 04/14/2026, the firm sent via the iOS App an "URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION" communication informing customers that a software error was identified within app versions 1.5 to 1.6 and G7 iOS / G7 Watch iOS app v2.9.0 through v2.11.2 that can cause the app display to flicker sequentially through previous estimated glucose values (EGVs) and trend arrows before displaying the current EGV and trend arrow with the potential to delay glucose alerts. Required Customer Actions: Updating from app versions 1.5-1.6 to the most current version is mandatory and you will not be able to use app versions 1.5 to 1.6 after April 30, 2026. Update your app now to continue using the app: 1. Tap Update App to go to the app store 2. Install the latest Dexcom ONE+ iOS app version or Dexcom G7 iOS app version that applies to customer app/product used . 3. Open the appropriate Dexcom ONE+ iOS app, or Dexcom G7 iOS app For questions or assistance - contact Technical Support by finding local Technical Support via Dexcom.com/global.
Quantity in commerce: 70212
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.
Product codes and lots: Lot Code: SW14244 versions 1.5.0 and 1.6.0 - UDI-DI: 00386270004307

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2165-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2163-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-11
Z-2164-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-11
Z-2165-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-05-20	2026-05-11

Product code QBJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)