Drugs & medicalClass I

Dexcom, Inc. recalls Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number:…

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…

Read the official notice →
Date
2025-11-05
Country
United States
Brand
Dexcom
Product
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number:…
Classification
Class I
Units
This product was distributed throughout the US. G6 Android US v1.15.0 SW11678…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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

  1. 2026-07-01
  2. US
    Drugs & medicalClass II

    Dexcom, Inc. recalls Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog…

    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.…

    FDA · DeviceDexcom, Inc.Dexcom does not have distribution records for this product due to its…Official notice →
  3. 2026-05-20
  4. US
    Drugs & medicalClass II

    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…

    FDA · DeviceDexcom, Inc.SW12300 & SW13355 Dexcom G7 iOS and watchOS app versions 2.9.0 through 2.11.2:…Official notice →
  5. 2025-09-10
  6. US
    Drugs & medicalClass I

    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…

    FDA · DeviceDexcom, Inc.SW12299 G7 Android CGM App Worldwide Distribution - US Nationwide and the…Official notice →
  7. 2025-06-25
  8. US
    Drugs & medicalClass I

    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 →
  9. 2025-06-11
  10. US
    Drugs & medicalClass II

    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 →
  11. 2025-02-26
  12. US
    Drugs & medicalClass II

    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 →
All 7 Dexcom recalls →

Other drugs & medical recalls in the United States

  1. 2025-11-05
  2. US
    Drugs & medicalClass II

    Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

    Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.

    FDA · DeviceCanon Medical System, USA, INC.US distribution to Ohio and NevadaOfficial notice →
  3. US
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    Alcon Research LLC recalls Alcon PRECISION1 One-Day Contact Lenses, -2.25D.

    Potential for a weak seal in some units resulting in compromise in sterility.

    FDA · DeviceAlcon Research LLCWorldwide - US distribution in the states of Alabama, Arizona, Arkansas,…Official notice →
  4. US
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    Surgical Theater Inc recalls SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

    A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.

    FDA · DeviceSurgical Theater IncWorldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA,…Official notice →
  5. US
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    ENDOMAGNETICS LTD recalls Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a…

    Potential for contamination with cotton fibers.

    FDA · DeviceENDOMAGNETICS LTDWorldwide - US Nationwide distribution in the states of CA, CO, CT, DC, FL,…Official notice →
  6. US
    Drugs & medicalClass II

    Aesculap Inc recalls Brand Name: Aesculap Product Name: SEALING UNIT F/10/12MM TROCARS W.REDUCER Model/Catalog Number: EK083P Software Version: N/A Product…

    It was determined there is the potential of silicone fragments detaching from the yellow sealing component.

    FDA · DeviceAesculap IncWorldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, MD,…Official notice →
  7. US
    Drugs & medicalClass II

    Alcon Research LLC recalls Brand Name: Alcon Laboratories, Inc. Product Name: Accessory devices for Unity and Constellation surgical consoles Model/Catalog Number:…

    Due to incomplete seals in the pouch which provide the sterile barrier.

    FDA · DeviceAlcon Research LLCWorldwide distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice →
See all drugs & medical recalls →