OmniPod Insulin Management System Starter Kit — Class II medical device recall Z-0165-2014
Terminated recall by Insulet Corporation, reported 2013-11-13, distributed nationwide. Alcohol Prep Pads contained within the kit are not properly labeled.
| Recall number | Z-0165-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Bedford, MA, United States |
| Recall initiated | 2013-09-27 |
| Classified | 2013-11-05 |
| Reported by FDA | 2013-11-13 |
| Terminated | 2014-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | IL |
| Quantity | 1,719 starter |
| Reason classes | labeling |
| Lot numbers | L13478, L13481, L13483, L13485 |
Product
OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries, a USB cable, a Users Guide, a Soft Carrying Case, a Troubleshooting guide, a Warranty Registration Card, and two Alcohol Pads. The OmniPod 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. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.
Reason for recall
Alcohol Prep Pads contained within the kit are not properly labeled.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0165-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.