Dexcom, Inc.

FDA Regulatory Profile

Summary

Total Recalls
25 (16 Class I)
510(k) Clearances
24
Inspections
12
Compliance Actions
3

Known Names

dexcom, dexcom malaysia, dexcom-malaysia-sdn-bhd, dexcom malaysia sdn bhd, dexcom international limited

Recent Recalls

NumberClassProductDate
Z-0318-2026Class IBrand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro AndroAugust 28, 2025
Z-2446-2025Class IBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App July 24, 2025
Z-2448-2025Class IBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App July 24, 2025
Z-2447-2025Class IBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App ModJuly 24, 2025
Z-2449-2025Class IBrand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM July 24, 2025
Z-2450-2025Class IBrand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App July 24, 2025
Z-1944-2025Class IDexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STKMay 12, 2025
Z-1945-2025Class IDexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-0May 12, 2025
Z-1943-2025Class IDexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)May 12, 2025
Z-1946-2025Class IDexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DOMay 12, 2025
Z-1906-2025Class IIDexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose MoMay 5, 2025
Z-1203-2025Class IIDexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001January 27, 2025
Z-1204-2025Class IIDexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001January 27, 2025
Z-1202-2025Class IIDexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001January 27, 2025
Z-1560-2020Class IIDexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous GlucoseFebruary 3, 2020
Z-1562-2020Class IIDexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose MonitoriFebruary 3, 2020
Z-1561-2020Class IIDexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose MonitoriFebruary 3, 2020
Z-1104-2020Class IIBrand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up November 19, 2019
Z-0929-2020Class IIDexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 andJuly 12, 2019
Z-1337-2016Class IDexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT224February 23, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose MonitoringFebruary 3, 2026
K253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose MonitoringDecember 17, 2025
K252818Dexcom Smart BasalNovember 18, 2025
K243214Dexcom G7 15 Day Continuous Glucose Monitoring SystemApril 9, 2025
K240902Dexcom G7 Continuous Glucose Monitoring SystemApril 23, 2024
K234070Stelo Glucose Biosensor SystemMarch 5, 2024
K234133Dexcom G7 Continuous Glucose Monitoring SystemFebruary 26, 2024
K231081Dexcom G7 Continuous Glucose Monitoring (CGM) SystemMay 15, 2023
K223931Dexcom G6 Continuous Glucose Monitoring (CGM) SystemJanuary 11, 2023
K213919Dexcom G7 Continuous Glucose Monitoring SystemDecember 7, 2022
K221259Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose MJuly 29, 2022
K203089Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemAugust 17, 2021
K201328Dexcom G6 Continuous Glucose Monitoring (CGM) SystemJuly 15, 2021
K200876Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose MonitorDecember 4, 2020
K193642Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) SystemJanuary 29, 2020
K192787Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) SystemOctober 25, 2019
K191833Dexcom G6 Pro Continuous Glucose Monitoring SystemOctober 7, 2019
K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose MonitorJune 28, 2019
K183206Dexcom G6 Continuous Glucose Monitoring SystemFebruary 14, 2019
K182405Dexcom Pro Q Continuous Glucose Monitoring SystemNovember 2, 2018