FDA Medical Device Recalls (openFDA)
Insulet Corporation: 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.
- Recall number
- Z-2485-2015
- 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.
- Status
- Terminated
- Initiated
- 2015-07-13
- Posted
- 2015-09-04
- Terminated
- 2017-01-26
- Reason
- 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
- 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
- 16,017 boxes. Expanded Recall: 5,179.0 boxes
- Distribution
- Worldwide Distribution: US (Nationwide) and country of: Switzerland.
- Lot, serial or model codes
- Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208 Expanded Recall: Lot Codes: L41908, L41910, F41935
- 510(k) numbers
- ["K122953"]
- PMA numbers
- not on file
- Product code
- LZG
- Firm FEI
- 3004464228
- Firm city
- Billerica
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28