Insulet Corporation 2024-01-10 Health critical FDA
Health · FDA · Recall #FDA-Z-0591-2024
Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3… Recall
Issued January 10, 2024 · Insulet Corporation
In January 2024, Insulet Corporation recalled the Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.
What you should do
- 1 Stop using Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Insulet Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Insulet Corporation
- Category
- Health
- Recall date
- January 10, 2024
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Germany and UK.
- Recall number
- FDA-Z-0591-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Insulet Corporation has 3 recalls in our database, including 3 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.