Insulet recalls Omnipod DASH insulin systems with mg/dL configuration due to potential bolus calculation errors after 2 months of use. Affected units may require replacement.
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 mg/dL configuration because the bolus calculator may become inaccurate after about two months of use. This could lead to incorrect insulin doses if the system fails to properly calculate insulin amounts.
After approximately two months of use, the device's data processing slows down, causing the bolus calculator to fail in accurately subtracting insulin on board (IOB) before suggesting insulin doses. This could result in incorrect insulin amounts being delivered.
People using Omnipod DASH insulin systems with mg/dL configuration for diabetes management. Those who have had the system for over two months are most at risk.
Check for the Omnipod DASH insulin system with mg/dL configuration, catalog number PT000010, and model M/D: INT1D001MG. The lot number L000202 is also associated with this recall.
Verify if your Omnipod DASH system has been in use for over two months and has the specified configuration and catalog number.
The bolus calculator may become inaccurate after about two months of use, potentially leading to incorrect insulin doses.
Check for the Omnipod DASH insulin system with mg/dL configuration, catalog number PT000010, model M/D: INT1D001MG, and lot number L000202.
The recall does not specify a remedy, so contact Insulet 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-2164-2020 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-2164-2020 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.
