Device recall: Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL)…
Class I FDA enforcement event 73412. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Class I, in the words of FDA
a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death
Dexcom Inc started this device recall on 23 Feb 2016. The firm address in the FDA record is in San Diego, CA. FDA put the recall in Class I. FDA event 73412 has 6 product records. The first FDA enforcement report date is 20 Apr 2016. The record gives the status Terminated, with the termination date 11 Aug 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK,…
Recalling firm
Dexcom Inc, San Diego, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1334-2016 | 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. | 131,768 | Class I | Terminated | 20 Apr 2016 |
| Z-1335-2016 | 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. | 18,004 | Class I | Terminated | 20 Apr 2016 |
| Z-1336-2016 | 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… | 5,722 | Class I | Terminated | 20 Apr 2016 |
| Z-1337-2016 | 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. | 53,106 | Class I | Terminated | 20 Apr 2016 |
| Z-1338-2016 | 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 persons with diabetes. | 19,586 | Class I | Terminated | 20 Apr 2016 |
| Z-1339-2016 | 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. | 41,925 | Class I | Terminated | 20 Apr 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2016
- 1,232
- Share of these events in Class I
- 3%
- Product records in this event
- 6Median of the firm: 3
- Events of the firm on the register
- 11
Other events of the firm
Official channels
- FDA enforcement report Z-1334-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 73412. https://recallregister.com/fda/i/73412/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK,…
- What quantity of product is in FDA event 73412?
- The event has 6 product records. The first record gives this quantity:
131,768
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 3% of the 1,232 device events that started in 2016 are in Class I.