Home / Recalls / Dexcom, Inc. / Z-2163-2026

Z-2163-2026 Class II Ongoing

Recalled by Dexcom, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
May 20, 2026
Initiation Date
April 14, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
58582

Product Description

Brand 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

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a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.

Distribution Pattern

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.

Code Information

Lot Code: SW12300 versions 2.9.0 through 2.11.2 - UDI-DI: 00386270001863

Other recalls by Dexcom, Inc.

  • Z-2165-2026 Class II — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc (April 14, 2026)
  • Z-2164-2026 Class II — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (April 14, 2026)
  • Z-0318-2026 Class I — Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom (August 28, 2025)
  • Z-2446-2025 Class I — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (July 24, 2025)
  • Z-2448-2025 Class I — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (July 24, 2025)
  • Z-2450-2025 Class I — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc (July 24, 2025)
  • Z-2447-2025 Class I — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (July 24, 2025)
  • Z-2449-2025 Class I — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc (July 24, 2025)
  • Z-1946-2025 Class I — Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 ( (May 12, 2025)
  • Z-1945-2025 Class I — Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 ( (May 12, 2025)