Z-0394-2016Class I

OmniPod, Insulin Management System (OUS) Catalog Number: 14810

Name: Z-0394-2016 OmniPod, Insulin Management System (OUS) Catalog Number: 14810
Creator: Insulet Corporation
Published: 2015-11-02
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2015-11-02 / Terminated

FDA source

Insulet Corporation began a recall of OmniPod, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod Insulin Management System is intended for subcutaneous delivery of... on 2015-11-02. FDA classified it as Class I and gives the reason as "Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0394-2016
Classification: Class I
Status: Terminated
Initiated: 2015-11-02
Posted: 2015-12-15
Terminated: 2017-03-07
Recalling firm: Insulet Corporation
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.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
FDA root cause: Process change control
Action: Insulet issued on 11/2/15 an URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes the problem that certain lots of the pod's needle failed to deploy or there is a delay in the deployment of the needle. Customers not responding to the email or Federal Express will receive additional mailing and/or follow up phone calls. Call Customer Care at 1-855-407-3729 if you have any questions regarding this Field Safety Notification.
Quantity in commerce: 5,179.0 boxes
Distribution: Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
Product codes and lots: Lot Codes: L41908, L41910, F41935

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0394-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0393-2016	Class I	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-15
Z-0394-2016	Class I	Terminated	Voluntary: Firm initiated	2015-12-23	2015-12-15

Product code LZG

K122953Class IIOmnipod Insulin Managment SystemInsulet Corporation / cleared 2012-12-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)