CLASS I Device recall · Reported 23 Dec 2015 · FDA Enforcement Report

OmniPod¿, Insulin Management System (US) recalled by Insulet

Insulet is recalling OmniPod¿, Insulin Management System (US), distributed nationwide in the US. The recall was initiated on 2 Nov 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907

Quantity recalled26,230.9 boxes

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-0393-2016
FDA event ID: 72535
Recalling firm: Insulet, Billerica, MA
Classification: Class I
Status: Terminated
Recall initiated: 2 Nov 2015
FDA classified: 15 Dec 2015
Reported: 23 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

2 Nov 2015	Recall initiated by company
15 Dec 2015	Classified by FDA	+43 days
23 Dec 2015	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

Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.

Product as listed by the FDA

OmniPod¿, Insulin Management System (US) Catalog Number: PODZXP420 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.

Where it was distributed

Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and Israel.

Nationwide

Questions about this recall

Why was it recalled?

Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.

Which lots are affected?

Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907

Where was it sold?

Worldwide Distribution - US Nationwide and countries of Switzerland, Germany, and 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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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 72535

This product is part of a recall event; the main page for the event is OmniPod¿, Insulin Management System (OUS) recalled by Insulet.

Reported	Class	Recall	Company	Reason	Where
23 Dec 2015	CLASS I	OmniPod¿, Insulin Management System (OUS) recalled by Insulet	Insulet	Other	Nationwide

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26 Aug 2026Device	CLASS II	MiniMed Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Other	CA
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