Omnipod 5 Automated Insulin Delivery System
FDA Device Recall #Z-2618-2023 — Class II — February 28, 2023
Recall Summary
| Recall Number | Z-2618-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 28, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Insulet Corporation |
| Location | Acton, MA |
| Product Type | Devices |
| Quantity | 11,016 users |
Product Description
Omnipod 5 Automated Insulin Delivery System
Reason for Recall
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.
Distribution Pattern
Distribution throughout the US
Lot / Code Information
PT-000559 Omnipod 5 App; all versions of software installed UDI-DI: 10385081120302
Other Recalls from Insulet Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0132-2026 | Class II | The failure occurs if a user on the Omnipod 5 i... | Sep 11, 2025 |
| Z-2016-2025 | Class II | Omnipod 5 Automated Insulin Delivery System, iO... | May 23, 2025 |
| Z-0591-2024 | Class I | Omnipod 5 App (on compatible Android smartphone... | Nov 30, 2023 |
| Z-0423-2023 | Class II | Omnipod 5 Automated Insulin Delivery System Pr... | Nov 14, 2022 |
| Z-0154-2023 | Class I | 18239: ASM Omnipod Dash PDM, insulin delivery s... | Oct 17, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.