Insulia Diabetes Management Companion — Class II medical device recall Z-0478-2019
Terminated recall by Voluntis, reported 2018-11-28, distributed in AZ, MI, OH, TN, VT. The firm identified an issue with the basal calculator identified on the Android version of the Insulia applic
| Recall number | Z-0478-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Voluntis, Suresnes, N/A, France |
| Recall initiated | 2018-10-08 |
| Classified | 2018-11-16 |
| Reported by FDA | 2018-11-28 |
| Terminated | 2019-03-12 |
| Distributed | AZ, MI, OH, TN, VT |
| Countries outside the US | CA, FR |
| Quantity | 14 |
Product
Insulia Diabetes Management Companion
Reason for recall
The firm identified an issue with the basal calculator identified on the Android version of the Insulia application. The bug could lead from low-impact to high-impact hypoglycemia depending on the circumstances. A new update of Insulia is now available (version 1.6.42), which resolves this issue.
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-0478-2019. 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.