Dexcom G6 Glucose Receiver — Class I medical device recall Z-1943-2025
Ongoing recall by Dexcom, Inc., reported 2025-06-25, distributed nationwide. Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit bo
| Recall number | Z-1943-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dexcom, Inc., San Diego, CA, United States |
| Recall initiated | 2025-05-12 |
| Classified | 2025-06-16 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BG, BH, CA, CH, CZ, DK, EE, ES, FI, FR, GB, GR, HK, HR, IE, IL, IT, JP, KR, LT, LU, LV, MT, NL, NO, NZ, OM, PL, RO, SA, SE, SI, SK, TR, ZA |
| Quantity | 36,824 units |
| UPC / GTIN / UDI-DI | 00386270003225, 00386270003232 |
| Model numbers | STK-FM-001, STK-FR-001 |
Product
Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1)
Reason for recall
Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death.
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-1943-2025. 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.