30 results · 29ms · Sources: EU EUDAMED, US FDA

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Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Recall
Terminated ·Dexcom Inc·Product code MDS·February 23, 2016

Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro Android US CGM App SW11678 version 1.15.0 Component: Dexcom G6 Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·August 28, 2025

Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics); MT22430-PNK, Receiver (mg/dL), Pink (pediatrics); MT22430-BLU, Receiver (mg/dL); Blue (pediatrics). Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Recall
Terminated ·Dexcom Inc·Product code MDS·February 23, 2016

Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, and the direction and rate of change of glucose levels in people with diabetes. The device is indicated to replace information obtained from standard blood glucose monitoring devices to make diabetes-related treatment decisions. The device also provides historical glucose information, facilitating long-term therapy adjustments.

FDA Recall
Terminated ·Dexcom Inc·Product code MDS·July 12, 2019

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·April 14, 2026

Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OR-001

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·January 27, 2025

Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·January 27, 2025

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.4.0 and earlier Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·July 24, 2025

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: versions 2.8.0 and earlier Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used of each are the same for each user. The watchOS app cannot be installed independently from the iOS phone app Component: Dexcom G7 CGM iOS App

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·July 24, 2025

Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·May 5, 2025

Dexcom One Continuous Glucose Monitoring System, SKUs(Part Number): STK-DO-006 (MT27409-1), STK-DO-013 (MT27409-1), STK-DO-103 (MT27409-2), STK-DO-109 (MT27409-2)

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·May 12, 2025

Dexcom One+ Continuous Glucose Monitoring System, SKU(Part Number): STK-D7-013 (MT28285-1), STK-D7-014 (MT28285-1), STK-D7-103 (MT28285-2)

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·May 12, 2025

Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.

FDA Recall
Terminated ·Dexcom Inc·Product code MDS·February 23, 2016

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS phone app and the versions used are the same for each user. The watchOS app cannot be installed independently from the iOS phone app. Component: Dexcom G7 Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·April 14, 2026

Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

FDA Recall
Terminated ·Dexcom Inc·Product code MDS·February 23, 2016

Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes.

FDA Recall
Terminated ·Dexcom Inc·Product code MDS·February 3, 2020

Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·April 14, 2026

Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·May 12, 2025

Dexcom G6, Continuous Glucose Monitoring System, REF: STK-OE-001

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·January 27, 2025

Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App SW12299 Component: Dexcom G7 Continuous Glucose Monitoring System

FDA Recall
Open, Classified ·Dexcom, Inc.·Product code QBJ·July 24, 2025