CLASS II Device recall · Reported 17 Mar 2021 · FDA Enforcement Report

Omnipod DASH Insulin Management System User Guide (OUS Only) Product recalled

Insulet is recalling Omnipod DASH Insulin Management System User Guide (OUS Only) Product. The recall was initiated on 1 Feb 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart 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

Quantity recalled21,723 guides

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-1203-2021
FDA event ID: 87305
Recalling firm: Insulet, Acton, MA
Classification: Class II
Status: Terminated
Recall initiated: 1 Feb 2021
FDA classified: 10 Mar 2021
Reported: 17 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Insulin Pumps & Glucose Monitors

Timeline

1 Feb 2021	Recall initiated by company
10 Mar 2021	Classified by FDA	+37 days
17 Mar 2021	Published in enforcement report	+7 days

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

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

Product as listed by the FDA

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

Where it was distributed

Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

Canada (French only), the Netherlands, France, Austria, Germany, Belgium, Greece, Turkey, Norway, Sweden, Denmark, and Finland

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.

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