Insulet recalls Omnipod 5 App for Android phones that may delay insulin control due to error messages. Users can switch to locked-down controller if needed. No serious injuries reported.
An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in therapy. To reduce the volume of inquiries Insulet was receiving from customers, an email was sent to all phone control users and the cause of the error message was resolved by reverting to prior certificates on the Insulet cloud to secure communications between the Omnipod 5 App sotware and the Insulet Cloud. This issue was limited to only certain compatible Android smartphones and did not affect the Omnipod 5 Pods or the dedicated locked-down Controller provided by Insulet. All other Omnipod 5 users were still able to manage their insulin with the device without use of the smartphone app and affected users were able to switch to the locked-down control provided to all users when they initiated the device during the time the App was unavailable to them. Further, the Omnipod itself continued to deliver insulin as per its pre-programmed settings so although affected users who did not have the locked-down controller readily available may not have been able to command insulin boluses during this time, they continued to receive basal insulin without interruption. Lastly, users of the Omnipod 5 were advised during training to always have backup supplies ready in the event of a device malfunction which would include alternative means to deliver insulin subcutaneously until the issue is resolved to minimize disruption to their insulin regimen. There were 2,168 complaints received out of 7,838 users with the Android compatible smartphones affected and 9 MDRs were submitted, however, there were no serious injuries reported or reports of erroneous results as the primary issue was a delay in therapy. This defect cannot cause false results that could negatively impact patients.
Insulet is recalling the Omnipod 5 App for certain Android smartphones because an error message may prevent users from controlling their insulin delivery system. This issue could cause delays in therapy but does not affect the Omnipod 5 Pods or the locked-down controller. No serious injuries were reported in the recall.
The error message prevents phone control of the insulin delivery system during certain app updates, potentially delaying therapy. However, users can switch to the locked-down controller for insulin management and the device continues delivering basal insulin without interruption.
People using the Omnipod 5 App with specific Android smartphones. Those without backup insulin delivery methods may face temporary delays in controlling insulin doses.
Check if you have the Omnipod 5 App installed on an Android smartphone. The issue affects only specific compatible Android models and does not impact the Omnipod 5 Pods or the locked-down controller.
Look for error messages when using the Omnipod 5 App on your Android smartphone. If you see this error, the app may not control your insulin delivery system.
If the app is unavailable, use the locked-down controller that comes with the Omnipod 5 device to manage insulin delivery.
No serious injuries were reported in the recall. The issue only causes delays in therapy, not false insulin results.
No. The app issue is limited to specific Android phones and users can switch to the locked-down controller if needed.
2,168 out of 7,838 users with the affected Android smartphones reported the issue.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-2618-2023 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-2618-2023 from Insulet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
