Food, drugs, devices › Insulet Corporation
Device recall: OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended f
FDA enforcement event 71651 is a device recall by Insulet Corporation of Billerica, MA, initiated 13 Jul 2015 and classified Class I, with 2 product records.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 4% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 26 Jan 2017. Initiation: voluntary: firm initiated. Insulet Corporation has 15 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Insulet Corporation, Billerica, MA.
Reason for recall
"OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin"
Distribution
"Worldwide Distribution: US (Nationwide) and country of: Switzerland."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2484-2015 | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. | 24829 boxes Expanded: 26,230.9 boxes | Class I | Terminated | 16 Sep 2015 |
| Z-2485-2015 | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. | 16,017 boxes. Expanded Recall: 5,179.0 boxes | Class I | Terminated | 16 Sep 2015 |
Context
Other enforcement events for Insulet Corporation
All 15 events for Insulet Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution: US (Nationwide) and country of: Switzerland."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Jan 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.