Z-1203-2021Class II

Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT...

Name: Z-1203-2021 Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT...
Creator: Insulet Corporation
Published: 2021-02-01
License: https://open.fda.gov/license/

Insulet Corporation / initiated 2021-02-01 / Terminated / root cause: labeling and UDI

FDA source

Insulet Corporation began a recall of Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French... on 2021-02-01. FDA classified it as Class II and gives the reason as "Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1203-2021
Classification: Class II
Status: Terminated
Initiated: 2021-02-01
Posted: 2021-03-10
Terminated: 2023-02-08
Recalling firm: Insulet Corporation
Product: Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
Product code: LZG Pump, Infusion, Insulin
Reason for recall: Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the User Guide, the text states that the comma (,) is not used for the decimal on the PDM, when in fact it is the period (.) that is not used.If a user were to use the period as a decimal separator when entering a bolus value, this decimal separator would not be recognized by the device and any numbers entered after the period could result in a larger value than intended
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Insulet issued Email, mail, or outbound call notification of the Field Safety Notification between Feb 2nd and Feb 5 th to end customers, HCPs and distributors in: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland. Letter states reason for correction, health risk and action to take: Please refer to the attached Annex in reference to page 6 of the User Guide as opposed to referring to the instructions in the existing User Guide. We recommend you place this insert at p.6 in your User Guide. Please ensure that the comma is always used when entering bolus values. In accordance with applicable rules, this corrective action is implemented with the knowledge of the relevant competent authorities. Please electronically confirm your understanding of this Field Safety Notification by going to the webpage the link below and following the instructions on screen.
Quantity in commerce: 21,723 guides
Distribution: Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland
Product codes and lots: Part Number/Rev./Country: PT 000002 AUT DEU mg 1, 2, 3 Guide, Dash User, German Austria PT 000002 BEL DEU MG 1, 2, 3 Guide, Dash User Guide, Belgium Germany, mgdl PT 000002 BEL FRE MG 1, 2, 3, 4 Guide, Dash User Guide, Belgium French, mgdl PT 000002 BEL NLD MG 1, 2, 3 Guide, Dash User Guide, Belgium Dutch, mgdl PT 000002 DEU DEU mg 1, 2, 3 Guide, Dash User Guide, German Germany, mgdl PT 000002 DEU DEU mm 1, 2, 3 Guide, Dash User Guide, German Germany, mmoll PT 000002 DNK DANmm 1, 2, 3 Guide, Dash User Guide, Danish Denmark PT 000002 FIN FIN mm 1, 2, 3 Guide, Dash User Guide, Finnish Finland PT 000002 FRA FRE mg 1, 2, 3, 4 Guide, Dash User Guide, French France PT 000002 NLD NLD mm 1, 2, 3, 4 Guide, Dash User Guide, Dutch Netherland PT 000002 NOR NORmm 1, 2, 3 Guide, Dash User Guide, Norwegian Norway PT 000002 SWE SWEmm 1, 2, 3 Guide, Dash User Guide, Swedish Sweden 41333 CAN 1, 2 User Guide, Omnipod, Dash, Canada PT 000318 1, 2 Guide, Dash User Guide, Greece PT 000319 1, 2 Guide, Dash User Guide, Turkey

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1203-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1203-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-10

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)