FDA Device recall Z-1335-2016

Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics)

FDA Device
Class I
terminated
Published 2016-04-20

On 2016-04-20 the FDA classified a Class I recall of Dexcom G4 PLATINUM (Pediatric) Receiver Receiver Part Number: MT22430 Receiver (mg/dL), Black (pediatrics) 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-1335-2016
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 (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.

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-KD-001 STK-KX-001 STR-KD-001 STK-KD-PNK STK-KX-PNK STR-KD-PNK STK-KD-BLU STK-KX-BLU S… 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

code_info

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 S…

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

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-1335-2016%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.