Omnipod DASH Insulin Management System User Guide — Class II medical device recall Z-1203-2021
Terminated recall by Insulet Corporation, reported 2021-03-17. Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemi
| Recall number | Z-1203-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Acton, MA, United States |
| Recall initiated | 2021-02-01 |
| Classified | 2021-03-10 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2023-02-08 |
| Countries outside the US | AT, BE, CA, DE, DK, FI, FR, GR, NL, NO, SE, TR |
| Quantity | 21,723 guides |
| Model numbers | 000002AUT, 000002XXX, 000318PT, 000319 |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1203-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.