DEXCOM INTERNATIONAL LIMITED

Activity by year

Devices registered here (1)

• Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
  Product code SBH (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1355

Recalls & enforcement

• Class IIOngoing2026-05-27
  Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G…
• Class IIOngoing2026-04-14
  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 th…
• Class IOngoing2025-08-28
  A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycem…
• Class IOngoing2025-07-24
  The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as th…
• Class IOngoing2025-05-12
  Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hy…
• Class IIOngoing2025-05-05
  A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, th…
• Class IIOngoing2025-01-27
  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 initi…
• Class IITerminated2020-02-03
  The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems.
• Class IITerminated2019-11-19
  It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application.
• Class IITerminated2019-07-12
  It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitializat…
• Class ITerminated2016-02-23
  Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.

Related

• All facilities operated by DEXCOM, INC.
• Dexcom (Malaysia) Sdn. Bhd. (MY)
• DEXCOM, INC. (CA)
• Dexcom, Inc. (AZ)
• Dexcom, Inc. (AZ)

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)