OmniPod¿ Insulin Management System — Class I medical device recall Z-2484-2015
Terminated recall by Insulet Corporation, reported 2015-09-16, distributed nationwide. OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be
| Recall number | Z-2484-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Billerica, MA, United States |
| Recall initiated | 2015-07-13 |
| Classified | 2015-09-04 |
| Reported by FDA | 2015-09-16 |
| Terminated | 2017-01-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH |
| Lot numbers | L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250, L41880, L41881, L41892, L41895, L41897, L41898, L41899, L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907 |
| Model numbers | POD-ZXP420 |
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.
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
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-2484-2015. 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.