Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
FDA Device Recall #Z-1797-2026 — Class I — March 12, 2026
Recall Summary
| Recall Number | Z-1797-2026 |
| Classification | Class I — Serious risk |
| Date Initiated | March 12, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Insulet Corporation |
| Location | Acton, MA |
| Product Type | Devices |
| Quantity | 1,240,115 units |
Product Description
Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7
Reason for Recall
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to the unexposed portion of the soft cannula during manufacturing, which would result in a compromised fluid path. The primary failure mode is pump under-delivery due to loss of insulin to an internal leak; in some cases, the defect may also lead to pump shutoff and cessation of insulin delivery when leaked insulin contacts Pod circuity in a manner that results in an electrical short. Under-delivery of insulin (both basal and bolus insulin) or cessation of insulin put users at risk of hyperglycemia, and complications from acute and chronic hyperglycemia, including dehydration, blurry vision, nausea, vomiting, altered mental status, diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar syndrome (HHS), or even death. Users may require hospitalization or medical intervention to treat severe adverse health consequences. Not all devices with the defect will issue an alarm or alert the user. If there is sufficient leakage of insulin to cause a short in the circuity, the Pod will issue a Hazard Alarm that stops all insulin delivery and alerts the user to replace their Pod. In addition, if a user s glucose is trending high and is not responding to insulin delivery, the system may reach the maximum amount of insulin microboluses allowed by the system and trigger the Automated Delivery Restriction (ADR) alert that tells users to check their blood glucose and take appropriate actions (i.e., ADR is a response to persistent hyperglycemia and maximum automated delivery constraints rather than a direct detection of the leak). The magnitude of under-delivery is unknown and based on multiple factors, including how much insulin is being delivered, whether an alarm and/or alert triggers, whether and when the user recognizes the device defect, the duration of Pod use, and the size of the tear.
Distribution Pattern
Nationwide distribution.
Lot / Code Information
Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7. UDI-DI: 10385083000527. Lot Codes: PH1U02252541, PH1U03282511, PH1U03282522, PH1U03312511, PH1U03312521, PH1U04012511, PH1U04012521, PH1U05052511, PH1U08162531, PH1U08182531, PH1U08182541, PH1U09242511, PH1U09242521, PH1U09242531, PH1U09252521, PH1U09252531, PH1U10152541, PH1U10162531, PH1U10162541, PH1U10172531, PH1U10172541, PH1U10182531, PH1U10182541, PH1U10202511, PH1U10202521, PH1U10202531, PH1U10202541, PH1U10212531, PH1U10212541, PH1U10222531, PH1U10222541, PH1U10232531, PH1U10232541, PH1U10242521, PH1U10242531, PH1U10242541.
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-2618-2023 | Class II | Omnipod 5 Automated Insulin Delivery System | Feb 28, 2023 |
| Z-0423-2023 | Class II | Omnipod 5 Automated Insulin Delivery System Pr... | Nov 14, 2022 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
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.