Class II — Voluntis
| Recalling firm | Voluntis |
|---|---|
| Registered facility | Voluntis (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Product | Insulia Diabetes Management Companion |
| Quantity | 14 |
| Distribution | Distributed to accounts in Arizona, Masachusetts, Michigan, Ohio, Tennessee, and Vermont. International distribution to Canada and France (however, French customers are not affected by this recall). |
| Initiated | 2018-10-08 |
| Classified | 2018-11-16 |
| Terminated | 2019-03-12 |
| Recall number | Z-0478-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Voluntis (Z-0478-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81508/
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