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 | Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism. |
| Product | OmniPod®, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod® Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. |
| Quantity | 26,230.9 boxes |
| Distribution | Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel. |
| Initiated | 2015-11-02 |
| Classified | 2015-12-15 |
| Terminated | 2017-03-07 |
| Recall number | Z-0393-2016 |
| 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-0393-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72535/
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