Insulet recalled 174,013 units of the Omnipod 5 iOS application on September 11, 2025. A software error can lead to the duplication of numbers during manual entry. This increases the risk of insulin overdelivery, potentially causing hypoglycemia.
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Insulet Corporation or your healthcare provider for instructions. Notification method: E-Mail
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The recall involves the Omnipod 5 App Software, specifically all software versions 2.X.X. The application is distributed nationwide in the U.S.
A user can inadvertently duplicate a single-digit entry when using the iPhone's magnifying feature. This duplication can result in incorrect bolus calculations, leading to insulin overdelivery.
The recall is classified as Class II. There have been no incidents reported as of the recall date, but the risk of hypoglycemia is significant.
Patients and healthcare providers should stop using the app immediately. Follow the instructions provided by Insulet Corporation via email or contact your healthcare provider.
For further information, contact Insulet Corporation or visit their website. Notification will be sent via email.
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