Facility

Voluntis

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3013530341
Establishment type	Manufacture Medical Device
Location	12-14 Rue Louis Bleriot Rueil-Malmaison Hauts-de-Seine, FR 92500
Registration status	Active · expires 2026
Parent company	Voluntis (owner-operator 10053592)
Brand names	Insulia Diabetes Management Companion

Activity by year

Recalls (1)

Devices registered here (1)

Calculator, Drug Dose
Product code NDC (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.1890

Recalls & enforcement

Class IITerminated2018-10-08
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 res…

All facilities operated by Voluntis

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Voluntis (FEI 3013530341) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013530341-voluntis/

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