Class I — Insulet Corporation
| Recalling firm | INSULET CORPORATION |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | 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 |
| Product | 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. |
| Quantity | 24829 boxes Expanded: 26,230.9 boxes |
| Distribution | Worldwide Distribution: US (Nationwide) and country of: Switzerland. |
| Initiated | 2015-07-13 |
| Classified | 2015-09-04 |
| Terminated | 2017-01-26 |
| Recall number | Z-2484-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Insulet Corporation (Z-2484-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71651/
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