Dexcom Inc: Medical Device Recall in 2020 - (Recall #: Z-1104-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.
Product Description:

Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804

Product Classification:

Class II

Date Initiated: November 19, 2019
Date Posted: February 19, 2020
Recall Number: Z-1104-2020
Event ID: 84436
Reason for Recall:

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.

Status: Terminated
Product Quantity: 237888 users registered.
Code Information:

Software Number: SW11677 Software Version: 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804

Distribution Pattern:

US Nation-wide OUS: Austria; Belgium; Canada; Czechia; Denmark; Finland; Germany; Great Britain; Hong Kong; Ireland; Italy; Luxembourg; Netherlands; Norway; South Africa; Spain; Sweden, and Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated