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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Receiver Kit Number: STK-PR-001 STK-CR-001 STR-PR-001 STK-PR-PNK STK-CR-PNK STR-PR-PNK STK-PR-BLU STK-CR-BLU STR-PR-BLU Lot Number: 5197950 5198382 5199018 5200680 5201286 5201394 5202064 5202065 5202311 5202779 5203297 5204321 5197967 5198434 5198901 5199013 5199213 5200586 5201276 5201288 5201391 5202073 5202074 5202420 5202801 5203631 5204325 5205014 5197968 5198378 5198896 5201272 5201376 5202084 5202085 5202432 5202881 5203322 5204328 5197951 5197952 5197953 5197954 5198371 5198372 5198373 5198381 5198488 5198489 5198490 5198491 5198511 5198711 5199020 5199021 5199206 5199208 5201231 5201232 5201283 5201284 5201388 5201389 5201995 5201998 5202066 5202067 5202068 5202069 5202070 5202071 5202072 5202308 5202417 5202421 5202780 5202877 5203320 5203472 5204962 5208005 5209676 5209677 5197955 5197956 5197957 5198374 5198409 5198418 5198419 5198435 5198436 5198437 5198450 5198613 5198710 5198898 5198902 5198998 5199000 5199017 5199215 5199216 5199217 5200587 5200652 5200653 5200654 5200655 5200656 5200657 5201233 5201234 5201243 5201247 5201248 5201249 5201277 5201278 5201279 5201287 5201386 5201393 5202075 5202076 5202077 5202078 5202079 5202080 5202081 5202082 5202307 5202412 5202418 5202799 5202896 5203291 5203316 5205000 5207992 5210398 5210399 5197958 5197959 5197960 5197961 5198375 5198376 5198377 5198386 5198387 5198427 5198447 5198712 5198742 5198743 5198744 5198900 5198999 5199019 5200588 5200589 5200590 5200591 5201235 5201236 5201237 5201238 5201239 5201273 5201274 5201997 5202086 5202093 5202094 5202095 5202096 5202423 5202428 5202785 5202802 5202878 5203286 5203328 5204311 5209680 5209681 5197910 5198379 5198899 5200522 5201285 5201387 5201398 5202312 5202424 5202897 5205010 5206620 5208805 5210020 5210067 5210394 5197966 5199016 5199214 5200583 5201250 5201275 5201289 5201385 5201390 5202083 5203292 5204317 5205020 5206583 5208006 5208818 5210021 5210036 5210471 5198380 5198886 5200584 5201271 5202017 5202115 5202415 5202789 5203289 5204340 5205001 5206617 5208032 5208811 5209505 5210022 5210039
- 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 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.
Product Codes/Lot Numbers:
Receiver Kit Number: STK-PR-001 STK-CR-001 STR-PR-001 STK-PR-PNK STK-CR-PNK STR-PR-PNK STK-PR-BLU STK-CR-BLU STR-PR-BLU Lot Number: 5197950 5198382 5199018 5200680 5201286 5201394 5202064 5202065 5202311 5202779 5203297 5204321 5197967 5198434 5198901 5199013 5199213 5200586 5201276 5201288 5201391 5202073 5202074 5202420 5202801 5203631 5204325 5205014 5197968 5198378 5198896 5201272 5201376 5202084 5202085 5202432 5202881 5203322 5204328 5197951 5197952 5197953 5197954 5198371 5198372 5198373 5198381 5198488 5198489 5198490 5198491 5198511 5198711 5199020 5199021 5199206 5199208 5201231 5201232 5201283 5201284 5201388 5201389 5201995 5201998 5202066 5202067 5202068 5202069 5202070 5202071 5202072 5202308 5202417 5202421 5202780 5202877 5203320 5203472 5204962 5208005 5209676 5209677 5197955 5197956 5197957 5198374 5198409 5198418 5198419 5198435 5198436 5198437 5198450 5198613 5198710 5198898 5198902 5198998 5199000 5199017 5199215 5199216 5199217 5200587 5200652 5200653 5200654 5200655 5200656 5200657 5201233 5201234 5201243 5201247 5201248 5201249 5201277 5201278 5201279 5201287 5201386 5201393 5202075 5202076 5202077 5202078 5202079 5202080 5202081 5202082 5202307 5202412 5202418 5202799 5202896 5203291 5203316 5205000 5207992 5210398 5210399 5197958 5197959 5197960 5197961 5198375 5198376 5198377 5198386 5198387 5198427 5198447 5198712 5198742 5198743 5198744 5198900 5198999 5199019 5200588 5200589 5200590 5200591 5201235 5201236 5201237 5201238 5201239 5201273 5201274 5201997 5202086 5202093 5202094 5202095 5202096 5202423 5202428 5202785 5202802 5202878 5203286 5203328 5204311 5209680 5209681 5197910 5198379 5198899 5200522 5201285 5201387 5201398 5202312 5202424 5202897 5205010 5206620 5208805 5210020 5210067 5210394 5197966 5199016 5199214 5200583 5201250 5201275 5201289 5201385 5201390 5202083 5203292 5204317 5205020 5206583 5208006 5208818 5210021 5210036 5210471 5198380 5198886 5200584 5201271 5202017 5202115 5202415 5202789 5203289 5204340 5205001 5206617 5208032 5208811 5209505 5210022 5210039
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1338-2016
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.