FDA Medical Device Recalls (openFDA)
Insulet Corporation: 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.
- Recall number
- Z-0394-2016
- 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.
- Status
- Terminated
- Initiated
- 2015-11-02
- Posted
- 2015-12-15
- Terminated
- 2017-03-07
- Reason
- Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
- 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
- 5,179.0 boxes
- Distribution
- Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.
- Lot, serial or model codes
- 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