The Recall Desk

FDA (Devices) recall action 73412

Dexcom Inc recalled 6 products on 2016-04-20

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2016-04-20
Critical
0
Units
270,111

Why these products were recalled

Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • SevereFDA (Devices)··2016-04-20

    Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 18,004 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.

    Product
    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…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2016-04-20

    Dexcom G5 Mobile Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 41,925 G5 Mobile Receivers because they may fail to provide intended audible alarms or alerts to users.

    Product
    Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL), Black; MT22719-PNK, Receiver (mg/dL), Pink; MT22719-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2016-04-20

    Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM Receivers with Share because they may fail to provide intended audible alarms or alerts.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2016-04-20

    Dexcom G4 Platinum Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM Receivers because they may fail to provide intended audible alarms or alerts to users.

    Product
    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.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2016-04-20

    Dexcom G4 PLATINUM Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling G4 PLATINUM receivers because they may fail to provide intended audible alarms or alerts for diabetes patients.

    Product
    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…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2016-04-20

    Dexcom G4 Platinum Pediatric Receiver Recall for Missing Audible Alarms

    Dexcom Inc is recalling 19,586 G4 Platinum Pediatric Receivers because they may fail to provide intended audible alarms or alerts.

    Product
    Dexcom G4 PLATINUM (Pediatric) Receiver with Share Receiver Part Number: MT22608 Receiver (mg/dL), Black (pediatrics); MT22608-PNK, Receiver (mg/dL), Pink (pediatrics); MT22608-BLU, Receiver (mg/dL), Blue (pediatrics). Intended to detect trends and track glucose patterns in…
    Category
    Distribution
    0 states