FDA Device recall Z-2485-2015
OmniPod¿ Insulin Management System
- FDA Device
- Class I
- terminated
- Published 2015-09-16
On 2015-09-16 the FDA classified a Class I recall of OmniPod¿ Insulin Management System by Insulet, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2485-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-07-13 |
| Published | 2015-09-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Insulet |
| Distribution | US |
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.
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
Identifiers
| code_info | Lot Numbers: L40771, L40892, L40901, L40905, L40997, L41199, L41208 Expanded Recall: 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-2485-2015%22
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