Home / Recalls / Dexcom, Inc. / Z-1202-2025

Z-1202-2025 Class II Ongoing

Recalled by Dexcom, Inc. — San Diego, CA

FDA device recall Z-1202-2025 was initiated by Dexcom, Inc. on January 27, 2025 and is designated Class II. Reason for recall: Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operat… The recall status is ongoing. Affected quantity: N/A.

Recall Details

Product Type
Devices
Report Date
February 26, 2025
Initiation Date
January 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

Reason for Recall

Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system .net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. At that time, the initial alarm/alert is delivered, but not the second one. Alarm/alerts will continue to be delayed and be one alarm/alert behind, causing delayed alarm/alerts until the receiver is reset. This condition could result in the missed detection of a hyperglycemic or hypoglycemic event. Second, a single EGV reading may be delayed for 5 minutes after the initial .net operating system error. If the user receives a single EGV reading delayed by 5 minutes, the delay is not expected to cause user harm.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC, NH, FL, CA, NJ, PR, GA and the countries of Austria, Belgium, Canada, Switzerland, Germany, Spain, France, Ireland, Japan, Netherlands, Slovenia, United Kingdom, Australia, Czech Republic, Denmark, Finland, France, Hong Kong, Israel, Italy, Korea, Kuwait, New Zealand, Norway, Oman, Poland, Qatar, Saudi Arabia, Singapore, Slovakia, South Africa, Sweden, Turkey, United Arab Emirates.

Code Information

All Serial Numbers/UDI: 00386270000583

Other recalls by Dexcom, Inc.

  • Z-2574-2026 Class II — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (May 27, 2026)
  • Z-2164-2026 Class II — Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom (April 14, 2026)
  • Z-2165-2026 Class II — Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc (April 14, 2026)
  • Z-2163-2026 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)

FDA data resources