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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Receiver Kit Number: STK-DR-001 STK-RR-001 STR-DR-001 STK-DR-PNK STK-RR-PNK STR-DR-PNK STK-DR-BLU STK-RR-BLU STR-DR-BLU Lot Number: 5197900 5197901 5197902 5197903 5197904 5197905 5197906 5197907 5197908 5197909 5197962 5197964 5197965 5198423 5198424 5198425 5198432 5198433 5198446 5198448 5198455 5198456 5198457 5198463 5198493 5198495 5198496 5198497 5198505 5198506 5198557 5198558 5198559 5198560 5198561 5198567 5198607 5198608 5198894 5198895 5199491 5200521 5200548 5200612 5200682 5200688 5200833 5200834 5201244 5201245 5201282 5201292 5201378 5201380 5201418 5201419 5201420 5201422 5201423 5202036 5202037 5202038 5202039 5202040 5202041 5202042 5202043 5202044 5202045 5202046 5202047 5202048 5202049 5202050 5202051 5202052 5202247 5202301 5202304 5202410 5202411 5202426 5202776 5202777 5202786 5202787 5202796 5202797 5202866 5202869 5202873 5202879 5203264 5203296 5203305 5203315 5203323 5203324 5203503 5204322 5204943 5204949 5205009 5205058 5206616 5206626 5206726 5207988 5208004 5208038 5208514 5208516 5208520 5208809 5208888 5209615 5209667 5209671 5210272 5197928 5197929 5197930 5197931 5197932 5197969 5197983 5198394 5198395 5198414 5198415 5198417 5198426 5198428 5198429 5198449 5198893 5199015 5199034 5199035 5199211 5199212 5200520 5200549 5200611 5200686 5200828 5201241 5201242 5201246 5201259 5201260 5201261 5201406 5201407 5201409 5201410 5201411 5202026 5202028 5202029 5202030 5202031 5202032 5202033 5202034 5202111 5202116 5202129 5202305 5202422 5202732 5202781 5202792 5202865 5202870 5202872 5203284 5203321 5203325 5203473 5204315 5204318 5204948 5205016 5206631 5208010 5208379 5208521 5208889 5209672 5209673 5210392 5197944 5197972 5197974 5197978 5197979 5197980 5198483 5198508 5198509 5198510 5198903 5199014 5199161 5199463 5199464 5199466 5200552 5200553 5200613 5200681 5201240 5201357 5201358 5201359 5201400 5201401 5201402 5201403 5201999 5202000 5202001 5202002 5202018 5202019 5202020 5202021 5202022 5202108 5202109 5202160 5202303 5202416 5202800 5202874 5202894 5202895 5203281 5203282 5203283 5203329 5203475 5203483 5204312 5204316 5204319 5204320 5204954 5205013 5206628 5207991 5208043 5208934 5209674 5209675 5197918 5197919 5197920 5197921 5197922 5198462 5198498 5198564 5201262 5201281 5201374 5201375 5201466 5202056 5202057 5202058 5202059 5202122 5202123 5202309 5202430 5202783 5202817 5202867 5202868 5203263 5203312 5203463 5203531 5204314 5204326 5204329 5204958 5205012 5209682 5209683 5197926 5197927 5197940 5197985 5200840 5201377 5202035 5202124 5202125 5202306 5202728 5202904 5203288 5204323 5204961 5209686 5209687 5197941 5197942 5197943 5198507 5201355 5201356 5202023 5202024 5202110 5202413 5202730 5202788 5202818 5202903 5203285 5203464 5204324 5205032 5209684 5197924 5198563 5200829 5200830 5200831 5200832 5200908 5200909 5201424 5202112 5202113 5202114 5202300 5202310 5202427 5202784 5203294 5203319 5204960 5206581 5207990 5208800 5209495 5210017 5210034 5210386 5197933 5198892 5200836 5200837 5200838 5200910 5200911 5201258 5202419 5202782 5202798 5203469 5205005 5206582 5207981 5208277 5208404 5208522 5209389 5209499 5210018 5210035 5210389 5197984 5198555 5200913 5200914 5200920 5200921 5201405 5202414 5202880 5204327 5204997 5206566 5207975 5208342 5208377 5208517 5209502 5210019 5210023 5210037
- 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 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.
Product Codes/Lot Numbers:
Receiver Kit Number: STK-DR-001 STK-RR-001 STR-DR-001 STK-DR-PNK STK-RR-PNK STR-DR-PNK STK-DR-BLU STK-RR-BLU STR-DR-BLU Lot Number: 5197900 5197901 5197902 5197903 5197904 5197905 5197906 5197907 5197908 5197909 5197962 5197964 5197965 5198423 5198424 5198425 5198432 5198433 5198446 5198448 5198455 5198456 5198457 5198463 5198493 5198495 5198496 5198497 5198505 5198506 5198557 5198558 5198559 5198560 5198561 5198567 5198607 5198608 5198894 5198895 5199491 5200521 5200548 5200612 5200682 5200688 5200833 5200834 5201244 5201245 5201282 5201292 5201378 5201380 5201418 5201419 5201420 5201422 5201423 5202036 5202037 5202038 5202039 5202040 5202041 5202042 5202043 5202044 5202045 5202046 5202047 5202048 5202049 5202050 5202051 5202052 5202247 5202301 5202304 5202410 5202411 5202426 5202776 5202777 5202786 5202787 5202796 5202797 5202866 5202869 5202873 5202879 5203264 5203296 5203305 5203315 5203323 5203324 5203503 5204322 5204943 5204949 5205009 5205058 5206616 5206626 5206726 5207988 5208004 5208038 5208514 5208516 5208520 5208809 5208888 5209615 5209667 5209671 5210272 5197928 5197929 5197930 5197931 5197932 5197969 5197983 5198394 5198395 5198414 5198415 5198417 5198426 5198428 5198429 5198449 5198893 5199015 5199034 5199035 5199211 5199212 5200520 5200549 5200611 5200686 5200828 5201241 5201242 5201246 5201259 5201260 5201261 5201406 5201407 5201409 5201410 5201411 5202026 5202028 5202029 5202030 5202031 5202032 5202033 5202034 5202111 5202116 5202129 5202305 5202422 5202732 5202781 5202792 5202865 5202870 5202872 5203284 5203321 5203325 5203473 5204315 5204318 5204948 5205016 5206631 5208010 5208379 5208521 5208889 5209672 5209673 5210392 5197944 5197972 5197974 5197978 5197979 5197980 5198483 5198508 5198509 5198510 5198903 5199014 5199161 5199463 5199464 5199466 5200552 5200553 5200613 5200681 5201240 5201357 5201358 5201359 5201400 5201401 5201402 5201403 5201999 5202000 5202001 5202002 5202018 5202019 5202020 5202021 5202022 5202108 5202109 5202160 5202303 5202416 5202800 5202874 5202894 5202895 5203281 5203282 5203283 5203329 5203475 5203483 5204312 5204316 5204319 5204320 5204954 5205013 5206628 5207991 5208043 5208934 5209674 5209675 5197918 5197919 5197920 5197921 5197922 5198462 5198498 5198564 5201262 5201281 5201374 5201375 5201466 5202056 5202057 5202058 5202059 5202122 5202123 5202309 5202430 5202783 5202817 5202867 5202868 5203263 5203312 5203463 5203531 5204314 5204326 5204329 5204958 5205012 5209682 5209683 5197926 5197927 5197940 5197985 5200840 5201377 5202035 5202124 5202125 5202306 5202728 5202904 5203288 5204323 5204961 5209686 5209687 5197941 5197942 5197943 5198507 5201355 5201356 5202023 5202024 5202110 5202413 5202730 5202788 5202818 5202903 5203285 5203464 5204324 5205032 5209684 5197924 5198563 5200829 5200830 5200831 5200832 5200908 5200909 5201424 5202112 5202113 5202114 5202300 5202310 5202427 5202784 5203294 5203319 5204960 5206581 5207990 5208800 5209495 5210017 5210034 5210386 5197933 5198892 5200836 5200837 5200838 5200910 5200911 5201258 5202419 5202782 5202798 5203469 5205005 5206582 5207981 5208277 5208404 5208522 5209389 5209499 5210018 5210035 5210389 5197984 5198555 5200913 5200914 5200920 5200921 5201405 5202414 5202880 5204327 5204997 5206566 5207975 5208342 5208377 5208517 5209502 5210019 5210023 5210037
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1337-2016
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.