Dexcom, Inc.
Dexcom, Inc. appears in FDA public data with 29 recalls — including 16 Class I (most serious) —, 27 510(k) clearances, 12 FDA inspections, and 3 compliance actions on record. Its most recent recall (Z-2574-2026, Class II) was initiated on May 27, 2026. Its most recent 510(k) clearance was granted on June 12, 2026.
Summary
- Total Recalls
- 29 (16 Class I)
- 510(k) Clearances
- 27
- Inspections
- 12
- Compliance Actions
- 3
Known Names
dexcom, dexcom malaysia, dexcom-malaysia-sdn-bhd, dexcom malaysia sdn bhd, dexcom international limited
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2574-2026 | Class II | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor | May 27, 2026 |
| Z-2163-2026 | Class II | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Mod | April 14, 2026 |
| Z-2165-2026 | Class II | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App | April 14, 2026 |
| Z-2164-2026 | Class II | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App | April 14, 2026 |
| Z-0318-2026 | Class I | Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Andro | August 28, 2025 |
| Z-2450-2025 | Class I | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App | July 24, 2025 |
| Z-2446-2025 | Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App | July 24, 2025 |
| Z-2447-2025 | Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Mod | July 24, 2025 |
| Z-2449-2025 | Class I | Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ Android CGM | July 24, 2025 |
| Z-2448-2025 | Class I | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App | July 24, 2025 |
| Z-1946-2025 | Class I | Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO | May 12, 2025 |
| Z-1944-2025 | Class I | Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403-0), STK | May 12, 2025 |
| Z-1943-2025 | Class I | Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1) | May 12, 2025 |
| Z-1945-2025 | Class I | Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-0 | May 12, 2025 |
| Z-1906-2025 | Class II | Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Mo | May 5, 2025 |
| Z-1202-2025 | Class II | Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 | January 27, 2025 |
| Z-1203-2025 | Class II | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 | January 27, 2025 |
| Z-1204-2025 | Class II | Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 | January 27, 2025 |
| Z-1562-2020 | Class II | Dexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitori | February 3, 2020 |
| Z-1560-2020 | Class II | Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose | February 3, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K260935 | Stelo Glucose Biosensor System | June 12, 2026 |
| K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | June 8, 2026 |
| K261359 | Stelo Glucose Biosensor System | May 21, 2026 |
| K253737 | Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring | February 3, 2026 |
| K253710 | Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring | December 17, 2025 |
| K252818 | Dexcom Smart Basal | November 18, 2025 |
| K243214 | Dexcom G7 15 Day Continuous Glucose Monitoring System | April 9, 2025 |
| K240902 | Dexcom G7 Continuous Glucose Monitoring System | April 23, 2024 |
| K234070 | Stelo Glucose Biosensor System | March 5, 2024 |
| K234133 | Dexcom G7 Continuous Glucose Monitoring System | February 26, 2024 |
| K231081 | Dexcom G7 Continuous Glucose Monitoring (CGM) System | May 15, 2023 |
| K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | January 11, 2023 |
| K213919 | Dexcom G7 Continuous Glucose Monitoring System | December 7, 2022 |
| K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose M | July 29, 2022 |
| K203089 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | August 17, 2021 |
| K201328 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | July 15, 2021 |
| K200876 | Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitor | December 4, 2020 |
| K193642 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System | January 29, 2020 |
| K192787 | Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System | October 25, 2019 |
| K191833 | Dexcom G6 Pro Continuous Glucose Monitoring System | October 7, 2019 |