Dexcom G4 PLATINUM — Class I medical device recall Z-1338-2016
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-1338-2016 |
|---|---|
| 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 | 19,586 |
| Lot numbers | 5197910, 5197950, 5197951, 5197952, 5197953, 5197954, 5197955, 5197956, 5197957, 5197958, 5197959, 5197960, 5197961, 5197966, 5197967, 5197968, 5198371, 5198372, 5198373, 5198374, 5198375, 5198376, 5198377, 5198378, 5198379, 5198380, 5198381, 5198382, 5198386, 5198387, 5198409, 5198418, 5198419, 5198427, 5198434, 5198435, 5198436, 5198437, 5198447, 5198450 and 199 more |
| Model numbers | MT22608 |
Product
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.
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-1338-2016. 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.