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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Dexcom Inc
- Reason for Recall:
- Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1335-2016
Related Recalls
A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis (DKA), or hyperosmolar hyperglycemic state (HHS).
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App . The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.
The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App . The affected App does not provide an expected "Sensor Failed" alert when the transmitter sends a "transmitterFailed" error message to the App when the CGM experiences a hardware or firmware failure. Instead, the App ends the CGM sensor session, stops reporting glucose values and displays the Start Sensor screen or No active sensor message without alerting the user, which can lead to missed detection of a hyperglycemic or hypoglycemic event and a delay in treatment.