# FDA recall Z-1203-2025

> **Dexcom, Inc.** · Class II · device recall initiated 2025-01-27.

## Product

Dexcom G6, Continuous Glucose Monitoring System, REF: STK-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

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.

## Key facts

- **Recall number:** Z-1203-2025
- **Recalling firm:** Dexcom, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-27
- **Report date:** 2025-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1203-2025

## Citation

> AI Analytics. FDA recall Z-1203-2025. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1203-2025. Source: US FDA. Licensed CC0.

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