CLASS I Device recall · Reported 20 Apr 2016 · FDA Enforcement Report
G4 Platinum (Pediatric) Receiver recalled by Dexcom
Dexcom is recalling G4 Platinum (Pediatric) 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
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-1335-2016
- 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 (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.
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.
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-KD-001 STK-KX-001 STR-KD-001 STK-KD-PNK STK-KX-PNK STR-KD-PNK STK-KD-BLU STK-KX-BLU STR-KD-BLU Lot Number: 5120310 5135364 5135371 5136498 5150416 5150452 5159486 5166429 5166430 5178449 5179449 5187476 5189594 5190724 5191132 5191133 5191174 5191809 5191810 5191849 5192890 5194119 5194120 5194121 5194431 5195411 5195746 5195763 5195776 5195784 5196133 5196159 5197032 5197033 5197647 5120312 5135362 5135368 5135380 5136502 5139380 5150418 5150454 5153433 5159487 5166433 5166449 5166450 5171430 5178418 5178456 5179453 5187474 5189590 5190725 5191105 5191134 5191135 5191408 5191839 5191840 5191841 5192942 5193958 5193959 5193960 5194123 5194432 5194433 5195412 5195459 5195747 5195766 5195965 5195969 5195972 5196087 5196134 5196918 5197034 5197035 5197614 5197615 5120311 5135363 5135366 5135381 5136500 5139379 5150417 5150453 5159488 5166434 5166435 5171431 5178451 5179451 5187426 5187475 5188748 5191106 5191136 5191409 5191836 5191837 5193810 5194186 5194335 5194400 5194563 5195413 5195745 5195768 5195785 5195973 5197036 5197037 5197038 5197608 5126237 5135369 5136504 5142406 5142408 5142415 5167425 5179455 5189600 5194188 5194562 5195759 5195786 5196151 5197648 5126238 5135370 5136505 5142417 5167426 5176427 5179457 5189602 5191151 5191838 5194192 5195760 5195787 5197563 5197649 5126239 5135361 5139386 5142416 5167427 5179456 5189601 5191103 5194190 5194191 5195761 5196995 5197650 5120293 5135365 5150455 5153439 5166437 5179450 5191101 5191811 5194201 5195416 5195966 5197505 5197571 5197676 5201468 5120294 5135379 5139382 5150439 5152419 5166440 5173415 5178458 5179454 5187477 5191099 5191410 5191812 5191848 5194202 5194561 5195415 5195750 5195793 5195967 5195976 5196156 5196157 5197641 5197642 5198439 5120309 5135367 5139381 5153441 5166438 5179452 5189593 5191100 5191813 5194212 5194213 5194565 5195414 5195764 5195968 5197638 5197639 5197678 5198441 5201469
Where was it sold?
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.
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 73412This product is part of a recall event; the main page for the event is G4 Platinum (Professional) Receiver recalled by Dexcom.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | G4 Platinum (Professional) Receiver recalled by Dexcom | Dexcom | Device Malfunction | Nationwide | |
| CLASS I | G4 Platinum Receiver recalled by Dexcom | Dexcom | Device Malfunction | Nationwide | |
| CLASS I | G5 Mobile Receiver recalled by Dexcom | Dexcom | Device Malfunction | Nationwide | |
| CLASS I | G4 Platinum (Pediatric) Receiver with Share Receiver recalled by Dexcom | Dexcom | Device Malfunction | Nationwide | |
| CLASS I | G4 Platinum Receiver with Share Receiver recalled by Dexcom | Dexcom | Device Malfunction | Nationwide |
More recalls from Dexcom
All 29| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 US Retail recalled | Dexcom | Device Malfunction | CA |
| Device | CLASS II | ONE+ iOS CGM App recalled by Dexcom | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 CGM iOS App recalled | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS II | G7 Continuous Glucose Monitoring System Dexcom G7 CGM watchOS App recalled | Dexcom | Device Malfunction | Nationwide |
| Device | CLASS I | G6 Continuous Glucose Monitoring System Dexcom G6 recalled | Dexcom | Device Malfunction | Nationwide |
Other Insulin Pumps & Glucose Monitors recalls
All 465| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |