Dexcom G4 PLATINUM — Class I medical device recall Z-1336-2016
Terminated recall by Dexcom Inc, reported 2016-04-20, distributed nationwide. Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
| Recall number | Z-1336-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dexcom Inc, San Diego, CA, United States |
| Recall initiated | 2016-02-23 |
| Classified | 2016-04-11 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2017-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CL, CO, CZ, DE, DK, ES, FI, FR, GB, HK, HU, IE, IL, IN, IT, KW, LB, NL, NO, NZ, PL, PT, QA, SE, SI, TR, ZA |
| Quantity | 5,722 |
| Lot numbers | 5176532, 5176533, 5176534, 5176535, 5176536, 5188586, 5189596, 5190560, 5191152, 5191737, 5191738, 5192934, 5193038, 5194193, 5194322, 5195147, 5195148, 5195352, 5195803, 5195913, 5196152, 5197013, 5197677, 5198614, 5200903, 5200904, 5200916, 5201455, 5201669, 5202100, 5202149, 5202429, 5202646, 5202790, 5202795, 5202803, 5202804, 5202906, 5203313, 5203474 and 11 more |
| Model numbers | MT20649 |
Product
Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black. Intended to detect trends and track glucose patterns in persons with diabetes. The G4 PLATINUM CGM System and G4 PLATINUM (Professional) CGM System use the same receiver, MT20649. The kits differ due to other kit contents, such as indications for use and professional receiver shield.
Reason for recall
Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1336-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.