CLASS II Device recall · Reported 28 Nov 2018 · FDA Enforcement Report

Insulia Diabetes Management Companion recalled by Voluntis

Voluntis is recalling Insulia Diabetes Management Companion, distributed in Arizona, Michigan, Ohio, Tennessee, Vermont. The recall was initiated on 8 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40

Quantity recalled14

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0478-2019
FDA event ID: 81508
Recalling firm: Voluntis, Suresnes, N/A
Classification: Class II
Status: Terminated
Recall initiated: 8 Oct 2018
FDA classified: 16 Nov 2018
Reported: 28 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Oct 2018	Recall initiated by company
16 Nov 2018	Classified by FDA	+39 days
28 Nov 2018	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Insulia Diabetes Management Companion

Where it was distributed

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).

Arizona Michigan Ohio Tennessee Vermont

Questions about this recall

Why was it recalled?

Which lots are affected?

Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40

Where was it sold?

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).

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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