Insulet Corporation has recalled approximately 174,013 units of the Omnipod 5 iOS application, specifically all software versions starting with 2.X.X. A software error occurs when a user uses the iPhone's magnifying feature while typing on the keyboard, which can cause single numbers in manual entry fields—such as insulin bolus doses or I:C ratios—to duplicate. If this error goes unnoticed, the device may deliver more insulin than intended. Consumers should contact their healthcare provider or Insulet Corporation for guidance on managing their insulin delivery while this issue is addressed.
The duplication of digits in insulin delivery fields can lead to the over-delivery of insulin, which may cause severe hypoglycemia (low blood sugar). Hypoglycemia is a serious condition that can lead to confusion, loss of consciousness, or seizures if not treated immediately.
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The failure occurs if a user selects and holds down on a manual entry field to magnify the visual field while simultaneously selecting a number on the keyboard.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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