FDA Device recall Z-0394-2016
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subc…
- FDA Device
- Class I
- terminated
- Published 2015-12-23
On 2015-12-23 the FDA classified a Class I recall of OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subc… by Insulet, citing pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0394-2016 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-11-02 |
| Published | 2015-12-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Insulet |
| Distribution | US |
Product
OmniPod¿, Insulin Management System (OUS) Catalog Number: 14810 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
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
Identifiers
| code_info | Lot Codes: L41908, L41910, F41935 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0394-2016%22
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