Z-0347-2020Class II

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

Name: Z-0347-2020 Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Creator: Insulet Corporation
Published: 2018-12-18
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2018-12-18 / Terminated / root cause: software

FDA source

Insulet Corporation began a recall of Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 on 2018-12-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0347-2020
Classification: Class II
Status: Terminated
Initiated: 2018-12-18
Posted: 2019-11-07
Terminated: 2020-05-13
Recalling firm: Insulet Corporation
Product: Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Product code: LZG Pump, Infusion, Insulin
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.
Root cause tag: software
FDA root cause: Software design
Action: Urgent Medical Device Correction letters dated 12/18/18 were sent to customers.
Quantity in commerce: 264
Distribution: US Nationwide.
Product codes and lots: Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0347-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0347-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-07

Product code LZG

K180045Class IIOmnipod DASH Insulin Management SystemInsulet Corporation / cleared 2018-06-01

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)