CLASS II Device recall · Reported 13 Nov 2019 · FDA Enforcement Report

Omnipod DASH Insulin Management System, Product recalled by Insulet

Insulet is recalling Omnipod DASH Insulin Management System, Product, distributed nationwide in the US. The recall was initiated on 18 Dec 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136

Quantity recalled264

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-0347-2020
FDA event ID: 82003
Recalling firm: Insulet, Billerica, MA
Classification: Class II
Status: Terminated
Recall initiated: 18 Dec 2018
FDA classified: 7 Nov 2019
Reported: 13 Nov 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Insulin Pumps & Glucose Monitors

Timeline

18 Dec 2018	Recall initiated by company
7 Nov 2019	Classified by FDA	+324 days
13 Nov 2019	Published in enforcement report	+6 days

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

Reason for recall

There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.

Product as listed by the FDA

Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.

Which lots are affected?

Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136

Where was it sold?

US 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

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14 Oct 2026Device	CLASS II	MiniMed Flex Insulin Pump recalled by Medtronic MiniMed	Medtronic MiniMed	Labeling Errors	Nationwide
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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