Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Omnipod DASH Insulin Management System (mmol/L configuration) Recalled by Insulet Corporation Due to After the device has been in use for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Insulet Corporation directly.
Affected Products
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Quantity: 1773
Why Was This Recalled?
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
Where Was This Sold?
The products were distributed to the following foreign countries: Italy, Netherlands, UK.
About Insulet Corporation
Insulet Corporation has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report