Insulet recalls Omnipod DASH insulin system with mmol/L configuration due to potential bolus calculation errors after 2 months of use. Affected units have specific catalog and lot numbers.
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.
Insulet is recalling Omnipod DASH insulin systems with mmol/L configuration because the bolus calculator may stop working correctly after about two months of use. This could lead to incorrect insulin doses being suggested, which might cause dangerous blood sugar levels.
After about two months of use, the device's data processing slows down, causing the bolus calculator to fail in subtracting insulin usage before suggesting a new insulin dose. This could result in incorrect insulin amounts being calculated, potentially leading to high blood sugar levels.
People using Omnipod DASH insulin systems with mmol/L configuration for diabetes management are affected. Those who have had the system for more than two months are most at risk.
Check for the catalog number PT000011 and lot numbers L000200, L000201, L000203, L000209, or L000210. The product uses mmol/L configuration and was sold with the M/D: INT1D001MM designation.
Verify if your Omnipod DASH system uses mmol/L configuration with catalog number PT000011 and lot numbers L000200, L000201, L000203, L000209, or L000210.
The recall is happening because after about two months of use, the bolus calculator may stop working correctly, leading to inaccurate insulin dose suggestions.
Check for the catalog number PT000011 and lot numbers L000200, L000201, L000203, L000209, or L000210. The product uses mmol/L configuration and was sold with the M/D: INT1D001MM designation.
The recall record does not specify a remedy, so contact Insulet Corporation directly for guidance.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-2165-2020 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-2165-2020 from Insulet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
