Z-2485-2015Class I

OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): 14810 (OUS)...

Name: Z-2485-2015 OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): 14810 (OUS)...
Creator: Insulet Corporation
Published: 2015-07-13
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2015-07-13 / Terminated / root cause: manufacturing process

FDA source

Insulet Corporation began a recall of OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set... on 2015-07-13. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2485-2015
Classification: Class I
Status: Terminated
Initiated: 2015-07-13
Posted: 2015-09-04
Terminated: 2017-01-26
Recalling firm: Insulet Corporation
Product: OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Product code: LZG Pump, Infusion, 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Insulet Corporation, sent an "URGENT: Voluntary Device Recall" letter dated 7/13/2015 to each consignee/customer via Email notification (where possible) on 7/13/15 as well as Federal Express. Customers not responding to the email or Federal Express will receive follow up phone calls. The letter described the product, problem and actions to e taken. The customers were instructed to do the following: If you have Pods from any of these lots, set them aside, we will replace them at no charge; arrange for return and replacement by choosing one of the following methods: 1. Complete the online form at https://www.myomnipod.com/podinfo (fastest method). 2. Return the enclosed reply card by mail or fax to 1-855-407-3729. 3. Contact Insulet Customer Care by calling 1-855-407-3729 (any time day or night). If you do not have any unused Pods form these lots, reply using one of the methods above. If you have any question, contact Acting VP RA/QA at 978-600-7000. EXPANDED RECALL: Insulet Corp. issued on 11/2/15 the URGENT: Field Safety Notification via Email notification and Federal Express. Letter describes problem of 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: 16,017 boxes. Expanded Recall: 5,179.0 boxes
Distribution: Worldwide Distribution: US (Nationwide) and country of: Switzerland.
Product codes and lots: Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208 Expanded Recall: Lot Codes: L41908, L41910, F41935

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2485-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2484-2015	Class I	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-04
Z-2485-2015	Class I	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-04

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)