Z-2165-2020Class II

Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM -

Name: Z-2165-2020 Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM -
Creator: Insulet Corporation
Published: 2020-04-02
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2020-04-02 / Terminated / root cause: design

FDA source

Insulet Corporation began a recall of Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery... on 2020-04-02. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2165-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-02
Posted: 2020-05-29
Terminated: 2021-09-14
Recalling firm: Insulet Corporation
Product: Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Product code: LZG Pump, Infusion, Insulin
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.
Root cause tag: design
FDA root cause: Device Design
Action: URGENT: Field Safety Notification letters dated 4/3/20 were sent to customers. How do users prevent this from happening? This issue is entirely preventable (see Figure 1 below) by (1) always entering the Bolus Calculator through the Bolus Button from the Home screen and (2) by never entering the Bolus Calculator through the Menu Icon. Is it safe for users to continue using the Omnipod DASH" PDM? Yes, it is safe for users to continue using the Omnipod DASH" PDM if the steps detailed above are followed to avoid incorrect bolus calculations. Users will not experience the issue if they always use the Bolus Calculator by entering through the Bolus Button on the Home screen. How will Insulet fix the software issue? A software update is being made to fix this issue, along with the issue described in the February 2020 notice and an updated replacement Omnipod DASH" PDM will be provided from August 2020. Once available, we will contact users directly via email or letter to arrange shipping. If you have received an email from Insulet providing you with the information covered in this letter and you have already responded, you do not need to do anything more at this time. If you have not received an email, we would ask that you go our website to confirm receipt of this letter and provide the Serial Number of your Omnipod DASH" PDM to ensure a replacement is reserved for you. If you would like additional information, our Customer Care is available 24/7 on 0800 011 6132 (+44 (0) 203 887 1709 when calling from abroad) or by email [email protected].
Quantity in commerce: 1773
Distribution: The products were distributed to the following foreign countries: Italy, Netherlands, UK.
Product codes and lots: UDI: PT000011 10385082000146; Lot Numbers: L000200, L000201, L000203, L000209, L000210

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2165-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2164-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29
Z-2165-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-10	2020-05-29

Product code LZG

K192659Class IIOmnipod Insulin Management System, Omnipod DASH Insulin Management SystemInsulet Corporation / cleared 2019-10-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)