CLASS II ONGOING Device recall · Reported 14 Dec 2022 · FDA Enforcement Report

Omnipod 5 Automated Insulin Delivery System Product recalled by Insulet

Insulet is recalling Omnipod 5 Automated Insulin Delivery System Product, distributed nationwide in the US. The recall was initiated on 14 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesALL serial numbers/ controller lots are currently in scope of this recall

Quantity recalled129,086

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-0423-2023
FDA event ID: 91127
Recalling firm: Insulet, Acton, MA
Classification: Class II
Status: Ongoing
Recall initiated: 14 Nov 2022
FDA classified: 7 Dec 2022
Reported: 14 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Insulin Pumps & Glucose Monitors

Timeline

14 Nov 2022	Recall initiated by company
7 Dec 2022	Classified by FDA	+23 days
14 Dec 2022	Published in enforcement report	+7 days

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

Reason for recall

The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan.

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 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM

Where it was distributed

Domestic distribution nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

ALL serial numbers/ controller lots are currently in scope of this recall

Where was it sold?

Domestic distribution nationwide.

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.

More recalls from Insulet

All 21

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS I	Omnipod (Eros) Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Omnipod DASH Pod recalled by Insulet	Insulet	Packaging Defects	Nationwide
8 Jul 2026Device	CLASS I	Omnipod 5 Pods recalled by Insulet	Insulet	Packaging Defects	Nationwide
22 Apr 2026Device	CLASS I	Omnipod 5 Pods recalled by Insulet	Insulet	Packaging Defects	Nationwide
22 Oct 2025Device	CLASS II	The failure occurs if a user on the Omnipod 5 iOS recalled by Insulet	Insulet	Device Malfunction	Nationwide

Other Insulin Pumps & Glucose Monitors recalls

All 467

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	MiniMed Flex Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Labeling Errors	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
6 Oct 2026Device	ANNOUNCED	StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip	Nova Biomedical	Device Malfunction
23 Sep 2026Device	CLASS I	StatStrip Glucose Hospital Meter System recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical	Nova Biomedical	Device Malfunction	Nationwide