CLASS I Device recall · Reported 20 Apr 2016 · FDA Enforcement Report

G4 Platinum (Professional) Receiver recalled by Dexcom

Dexcom is recalling G4 Platinum (Professional) Receiver, distributed nationwide in the US. The recall was initiated on 23 Feb 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesReceiver Kit Number: STK-PU-001 Lot Number: 5176532 5176533 5176534 5176535 5176536 5188586 5189596 5190560 5191152 5191737 5191738 5192934 5193038 5194193 5194322 5195147 5195148 5195352 5195803 5195913 5196152 5197013 5197677 5198614 5200903 5200904 5200916 5201455 5201669 5202100 5202149 5202429 5202646 5202790 5202795 5202803 5202804 5202906 5203313 5203474 5203485 5203536 5204330 5204333 5205041 5206612 5206643 5208018 5208332 5208810 5210472

Quantity recalled5,722

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1336-2016
FDA event ID: 73412
Recalling firm: Dexcom, San Diego, CA
Classification: Class I
Status: Terminated
Recall initiated: 23 Feb 2016
FDA classified: 11 Apr 2016
Reported: 20 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

23 Feb 2016	Recall initiated by company
11 Apr 2016	Classified by FDA	+48 days
20 Apr 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution-US (nationwide), Canada, Italy, Netherlands, Belgium, Norway, New Zealand, Poland, Sweden, Denmark, Slovenia, Turkey, South Africa, India, Israel, Hungary, Hong Kong, UK, Ireland, France, Finland, Spain, Portugal, Colombia, Chile, Germany, Austria, Switzerland, Kuwait, United Arab Emirates, Australia, Czech Republic, Bahrain, Lebanon, and Qatar.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Receiver Kit Number: STK-PU-001 Lot Number: 5176532 5176533 5176534 5176535 5176536 5188586 5189596 5190560 5191152 5191737 5191738 5192934 5193038 5194193 5194322 5195147 5195148 5195352 5195803 5195913 5196152 5197013 5197677 5198614 5200903 5200904 5200916 5201455 5201669 5202100 5202149 5202429 5202646 5202790 5202795 5202803 5202804 5202906 5203313 5203474 5203485 5203536 5204330 5204333 5205041 5206612 5206643 5208018 5208332 5208810 5210472

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 73412

Reported	Class	Recall	Company	Reason	Where
20 Apr 2016	CLASS I	G4 Platinum (Pediatric) Receiver recalled by Dexcom	Dexcom	Device Malfunction	Nationwide
20 Apr 2016	CLASS I	G4 Platinum Receiver recalled by Dexcom	Dexcom	Device Malfunction	Nationwide
20 Apr 2016	CLASS I	G5 Mobile Receiver recalled by Dexcom	Dexcom	Device Malfunction	Nationwide
20 Apr 2016	CLASS I	G4 Platinum (Pediatric) Receiver with Share Receiver recalled by Dexcom	Dexcom	Device Malfunction	Nationwide
20 Apr 2016	CLASS I	G4 Platinum Receiver with Share Receiver recalled by Dexcom	Dexcom	Device Malfunction	Nationwide

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23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide