CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report

Omnipod DASH Insulin Management System (mg/dL configuration) recalled

Insulet is recalling Omnipod DASH Insulin Management System (mg/dL configuration). The recall was initiated on 2 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: PT - 000010 - 10385082000139; Lot Numbers: L000202

Quantity recalled400

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-2164-2020
FDA event ID: 85552
Recalling firm: Insulet, Acton, MA
Classification: Class II
Status: Terminated
Recall initiated: 2 Apr 2020
FDA classified: 29 May 2020
Reported: 10 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

2 Apr 2020	Recall initiated by company
29 May 2020	Classified by FDA	+57 days
10 Jun 2020	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

After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.

Product as listed by the FDA

Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is 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

The products were distributed to the following foreign countries: Italy, Netherlands, UK.

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: PT - 000010 - 10385082000139; Lot Numbers: L000202

Where was it sold?

The products were distributed to the following foreign countries: Italy, Netherlands, UK.

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 85552

Reported	Class	Recall	Company	Reason	Where
10 Jun 2020	CLASS II	Omnipod DASH Insulin Management System (mmol/L configuration) recalled	Insulet	Other	MA

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