🔍 RecallPedia

Insulia Diabetes Management Companion

Class I - Dangerous
🏥 Medical Devices Recalled: October 8, 2018 Voluntis Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Voluntis
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Insulia Diabetes Management Companion

Product Codes/Lot Numbers:

Software version numbers 1.4.3 / 1.6.3 / 1.6.31 / 1.6.40

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0478-2019