Lower risk Medical device recall · FDA · Published February 1, 2021

Insulet Omnipod DASH User Guide Misprint Risk: Incorrect Insulin Dose

Insulet recalls Omnipod DASH insulin management system user guides with a misprint that could cause incorrect insulin doses and hypoglycemia for users outside the US. Affected guides include specific language versions sold in Canada, Germany, France, and other countries.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1203-2021Medical device Insulet ›

Lower-risk 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

Take action

Contact the company

Recalling firmInsulet Corporation100 Nagog Park · Acton, MA 01720-3440

✎ GovInfoNow plain-language explainer

Insulet is recalling user guides for the Omnipod DASH insulin management system that contain a misprint. This error could lead to incorrect insulin doses if users mistakenly use a period instead of a comma for decimal separators, potentially causing hypoglycemia. Read more at govinfonow.com/recall/63322-insulet-omnipod-dash-user-guide-misprint-risk-incorrect-insulin-dose.

Source Summary by GovInfoNow · govinfonow.com/recall/63322-insulet-omnipod-dash-user-guide-misprint-risk-incorrect-insulin-dose · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1203-2021

Cite this page

“Insulet Omnipod DASH User Guide Misprint Risk: Incorrect Insulin Dose.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63322-insulet-omnipod-dash-user-guide-misprint-risk-incorrect-insulin-dose. Based on FDA recall #Z-1203-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1203-2021%22&limit=1).

The FDA announced on Feb. 1, 2021, that Insulet Corporation is recalling Omnipod DASH Insulin Management System User Guides for use outside the U.S. due to a misprint that could cause incorrect bolus delivery and hypoglycemia.

How to tell if you have it

Brand: Insulet
Product: Omnipod DASH Insulin Management System User Guide (OUS Only)
Catalog Numbers: PT 000002 XXX XXX XX, PT 000318, PT 000319
Specific Part Numbers/Revisions: PT 000002 AUT DEU mg 1, 2, 3; PT 000002 BEL DEU MG 1, 2, 3; PT 000002 BEL FRE MG 1, 2, 3, 4; PT 000002 BEL NLD MG 1, 2, 3; PT 000002 DEU DEU mg 1, 2, 3; PT 000002 DEU DEU mm 1, 2, 3; PT 000002 DNK DANmm 1, 2, 3; PT 000002 FIN FIN mm 1, 2, 3; PT 000002 FRA FRE mg 1, 2, 3, 4; PT 000002 NLD NLD mm 1, 2, 3, 4; PT 000002 NOR NORmm 1, 2, 3; PT 000002 SWE SWEmm 1, 2, 3; 41333 CAN 1, 2; PT 000318 1, 2; PT 000319 1, 2

The hazard

According to the FDA, certain foreign user guides include a misprint on page 6 stating that the comma is not used for the decimal on the PDM, when in fact it is the period. If a user enters a bolus value using a period as the decimal separator, the device will not recognize it, potentially resulting in a larger insulin delivery than intended and causing hypoglycemia.

Context

GovInfoNow's records show Insulet Corporation has had 11 other recalls since Dec. 18, 2018. Recent Insulet recalls include the Omnipod Eros Pod recall on May 20, 2026, for insulin leaking risk, and the Omnipod 5 Pods recall on March 12, 2026, for internal leak risk from manufacturing defects. Other recent recalls of similar products include Tand pumps with Czech guide errors (Jan. 30, 2026), Medtronic MiniMed 780G insulin pump software error causing stoppage (May 27, 2026), and Medtronic MiniMed 780G risk of incorrect insulin delivery (July 13, 2026).

How to tell if you have this one

Check if you have the Omnipod DASH user guide with the product catalog number PT 000002 in the following countries: Canada, Germany, France, Belgium, Netherlands, Austria, Sweden, Norway, Denmark, Finland, Turkey, and Greece. The guide may be in German, French, Dutch, or other languages as specified.

Brand
Insulet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check User Guide Version
Verify your Omnipod DASH user guide has the product catalog number PT 000002 and matches the country-specific language version listed in the recall.

How this recall unfolded

Recall timeline

FDA terminated this recall 2 years after the firm started it.

Feb 1, 2021Firm started the recall
Mar 10, 2021FDA classified it Class II
Mar 17, 2021Published in FDA’s Enforcement Report
Feb 8, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63322-insulet-omnipod-dash-user-guide-misprint-risk-incorrect-insulin-dose">Insulet Omnipod DASH User Guide Misprint Risk: Incorrect Insulin Dose (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1203-2021 (February 1, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1203-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.