CLASS I Device recall · Reported 16 Sep 2015 · FDA Enforcement Report

OmniPod¿ Insulin Management System recalled by Insulet

Insulet is recalling OmniPod¿ Insulin Management System, distributed nationwide in the US. The recall was initiated on 13 Jul 2015 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot Numbers: L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250 Expanded Recall: Lot Codes: L41880, L41881, L41892, L41895,L41897,L41898, L41899,L41900, L41901, L41902, L41903, L41904, L41905, L41906, L41907

Quantity recalled24829 boxes Expanded: 26,230.9 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-2484-2015
FDA event ID: 71651
Recalling firm: Insulet, Billerica, MA
Classification: Class I
Status: Terminated
Recall initiated: 13 Jul 2015
FDA classified: 4 Sep 2015
Reported: 16 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

13 Jul 2015	Recall initiated by company
4 Sep 2015	Classified by FDA	+53 days
16 Sep 2015	Published in enforcement report	+12 days

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

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Where it was distributed

Worldwide Distribution: US (Nationwide) and country of: Switzerland.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot Numbers: L40806, L40811, L40895, L40976, L41014, L41025, L41067, L41162, L41171, L41197, L41198, L41250 Expanded Recall: 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 country of: Switzerland.

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 71651

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

Reported	Class	Recall	Company	Reason	Where
16 Sep 2015	CLASS I	OmniPod¿ Insulin Management System recalled by Insulet	Insulet	Device Malfunction	Nationwide

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