FDA recall, , Moderate risk
Dexcom G7 CGM iOS, G7 CGM watchOS, and ONE+ iOS CGM App
The Dexcom G7 CGM iOS App has a software defect that can delay glucose alerts.
Summary by Recall Canary from the FDA notice
What happened
Dexcom, Inc., of San Diego, California, recalled the Dexcom G7 CGM iOS App, the Dexcom G7 CGM watchOS App, and the Dexcom ONE+ iOS CGM App because a software defect can block the processing of estimated glucose values (EGVs) and trend arrows. When the app runs in the background, EGV notifications may queue up and replay sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs.
The recall began April 14, 2026, and the FDA added it to its Enforcement Report on May 11, 2026. The affected apps include Dexcom G7 iOS and watchOS app versions 2.9.0 through 2.11.2, distributed nationwide in the U.S. and internationally, and Dexcom ONE+ iOS app versions 1.5.0 and 1.6.0, distributed only internationally.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Match the UDI-DI, lot code and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Dexcom ONE+ Continuous Glucose Monitoring System Dexcom ONE+ iOS CGM App
- UDI-DI
- 00386270004307
- Model/Catalog number
- SW14244
- Lot code
- 1.5.0
- 1.6.0
- Software version
- versions 1.5.0 and 1.6.0
Dexcom G7 Continuous Glucose Monitoring System Dexcom G7 CGM watchOS App
- UDI-DI
- 00386270005168
- Model/Catalog number
- SW13355
- Lot code
- 2.9.0
- 2.11.2
- Software version
- Versions 2.9.0 through 2.11.2
Dexcom G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App
- UDI-DI
- 00386270001863
- Model/Catalog number
- SW12300
- Lot code
- 2.9.0
- 2.11.2
- Software version
- Versions 2.9.0 through 2.11.2
Recall details
- Company began the recall
- Sold in
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.
- Company
- Dexcom, Inc.San Diego, California
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98639
- Recall numbers
- Z-2163-2026 to Z-2165-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
