FDA-Device2019-11-13Class II
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Hazard
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.
Sold states
US Nationwide.
Affected count
264
Manufactured in
600 Technology Park Dr Ste 200, N/A, Billerica, MA, United States
Products
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0347-2020More Insulet Corporation recalls
- FDA-Device2026-07-08Insulet Omnipod 5 Pods recalled for insulin leakage risk due to manufacturing defect
- FDA-Device2026-07-08Insulet Omnipod DASH Pod recalled for insulin leakage risk during manufacturing
- FDA-Device2026-07-08Insulet Omnipod Eros insulin pump pods recalled for potential under-delivery due to cannula damage
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