FDA Device recall Z-1337-2016

Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black

FDA Device
Class I
terminated
Published 2016-04-20

On 2016-04-20 the FDA classified a Class I recall of Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black by Dexcom, citing customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1337-2016
Classification	Class I
Status	terminated
Initiated	2016-02-23
Published	2016-04-20
Last updated	2026-09-13 11:54 UTC
Company	Dexcom
Distribution	US

Product

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.

Reason

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

Identifiers

code_info	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 S… 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

code_info

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 S…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1337-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.