Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Insulia Diabetes Management Companion Recalled by Voluntis Due to The firm identified an issue with the basal...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Voluntis directly.
Affected Products
Insulia Diabetes Management Companion
Quantity: 14
Why Was This Recalled?
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.
Where Was This 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).
About Voluntis
Voluntis has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report