OmniPod¿ — Class I medical device recall Z-0393-2016
Terminated recall by Insulet Corporation, reported 2015-12-23, distributed nationwide. Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
| Recall number | Z-0393-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Billerica, MA, United States |
| Recall initiated | 2015-11-02 |
| Classified | 2015-12-15 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2017-03-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DE, IL |
| Quantity | 26,230 |
| Lot numbers | L41880, L41881, L41892, L41895, L41897, L41898, L41899, L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907 |
| Model numbers | PODZXP420 |
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.
Reason for recall
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0393-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.