CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report

OmniPod Insulin Management System Starter Kit recalled by Insulet

Insulet is recalling OmniPod Insulin Management System Starter Kit, distributed nationwide in the US. The recall was initiated on 27 Sep 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: L13483, L13485, L13478, & L13481

Quantity recalled1,719 starter kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0165-2014
FDA event ID: 66425
Recalling firm: Insulet, Bedford, MA
Classification: Class II
Status: Terminated
Recall initiated: 27 Sep 2013
FDA classified: 5 Nov 2013
Reported: 13 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

27 Sep 2013	Recall initiated by company
5 Nov 2013	Classified by FDA	+39 days
13 Nov 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Alcohol Prep Pads contained within the kit are not properly labeled.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - USA Nationwide and the country of Israel.

Nationwide

Questions about this recall

Why was it recalled?

Alcohol Prep Pads contained within the kit are not properly labeled.

Which lots are affected?

Lot Numbers: L13483, L13485, L13478, & L13481

Where was it sold?

Worldwide Distribution - USA Nationwide and the country of Israel.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 66425

This product is part of a recall event; the main page for the event is OmniPod Insulin Management Product Demonstration Kit recalled by Insulet.

Reported	Class	Recall	Company	Reason	Where
13 Nov 2013	CLASS II	OmniPod Insulin Management Product Demonstration Kit recalled by Insulet	Insulet	Other	Nationwide

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