Dario Blood Glucose Monitoring System — Class II medical device recall Z-0260-2020
Terminated recall by LABSTYLE INNOVATIONS, reported 2019-11-06, distributed nationwide. The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood g
| Recall number | Z-0260-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LABSTYLE INNOVATIONS, Ramat Gan, Israel |
| Recall initiated | 2019-08-29 |
| Classified | 2019-10-31 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB, IT |
| Model numbers | 1015-05 |
Product
Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2
Reason for recall
The Dario-Blood Glucose Tracker Android App versions 4.3.0-4.3.2 may experience duplicate logging of a blood glucose level reading.
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-0260-2020. 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.