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Dexcom, Inc.

24 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Reta recall (Z-2574-2026)Dexcom, Inc.2026-06-24
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS recall (Z-2163-2026)Dexcom, Inc.2026-05-11
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM wat recall (Z-2164-2026)Dexcom, Inc.2026-05-11
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS recall (Z-2165-2026)Dexcom, Inc.2026-05-11
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 recall (Z-0318-2026)Dexcom, Inc.2025-10-30
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM And recall (Z-2446-2025)Dexcom, Inc.2025-09-04
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS recall (Z-2447-2025)Dexcom, Inc.2025-09-04
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM wat recall (Z-2448-2025)Dexcom, Inc.2025-09-04
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ And recall (Z-2449-2025)Dexcom, Inc.2025-09-04
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS recall (Z-2450-2025)Dexcom, Inc.2025-09-04
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT274 recall (Z-1943-2025)Dexcom, Inc.2025-06-16
Dexcom G7 Glucose Receiver, SKUs (part number): STK-AT-011(MT26403-0), STK-AT-012 (MT26403 recall (Z-1944-2025)Dexcom, Inc.2025-06-16
Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1) recall (Z-1945-2025)Dexcom, Inc.2025-06-16
Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1) recall (Z-1946-2025)Dexcom, Inc.2025-06-16
Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous recall (Z-1906-2025)Dexcom, Inc.2025-06-04
Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 recall (Z-1202-2025)Dexcom, Inc.2025-02-20
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001 recall (Z-1203-2025)Dexcom, Inc.2025-02-20
Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001 recall (Z-1204-2025)Dexcom, Inc.2025-02-20
Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649 recall (Z-1334-2016)Dexcom Inc2016-04-11
Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Bl recall (Z-1335-2016)Dexcom Inc2016-04-11
Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), recall (Z-1336-2016)Dexcom Inc2016-04-11
Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Bla recall (Z-1337-2016)Dexcom Inc2016-04-11
Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver recall (Z-1338-2016)Dexcom Inc2016-04-11
Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-P recall (Z-1339-2016)Dexcom Inc2016-04-11

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