Dexcom, Inc. recalls Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software…
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…
Read the official notice →- Date
- 2025-09-10
- Country
- United States
- Brand
- Dexcom
- Product
- Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software…
- Classification
- Class I
- Units
- SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Dexcom recalls
- 2026-07-01
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Dexcom, Inc. recalls Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software…
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…
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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…
FDA · DeviceDexcom, Inc.This product was distributed throughout the US. G6 Android US v1.15.0 SW11678…Official notice → - 2025-06-25
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Dexcom, Inc. recalls Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)
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…
FDA · DeviceDexcom, Inc.worldwide distribution - US Nationwide and the countries of Andorra, Argentina…Official notice → - 2025-06-11
- US
Dexcom, Inc. recalls Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
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…
FDA · DeviceDexcom, Inc.Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice → - 2025-02-26
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Dexcom, Inc. recalls Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001
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…
FDA · DeviceDexcom, Inc.Worldwide - US Nationwide distribution in the states of OH, TX, PA, MN, SC,…Official notice →
Other drugs & medical recalls in the United States
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Medtronic Perfusion Systems recalls DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
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mo-Vis BVBA recalls IDM-MICRO-R. Electrical wheelchair component.
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