Insulet recalls Omnipod DASH Personal Diabetes Manager (PDM) software versions 1.0.50 and earlier due to potential inaccurate insulin dosing, which could cause dangerous low or high blood sugar levels.
In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as designed or when a system alarm interrupts a bolus calculation. If the user delivers the bolus, this may lead to hypoglycemia or hyperglycemia.
Insulet is recalling Omnipod DASH Personal Diabetes Manager devices with software versions 1.0.50 and earlier because they may suggest incorrect insulin doses when blood glucose readings are more than 10 minutes old. This could lead to dangerously low or high blood sugar levels if the user administers the dose.
The device may calculate an inaccurate insulin dose if the blood glucose reading used is more than 10 minutes old and the user doesn't exit the bolus calculator as designed. If the user delivers the dose, it could cause dangerously low (hypoglycemia) or high (hyperglycemia) blood sugar levels.
People using Omnipod DASH PDM devices with software versions 1.0.50 and earlier are affected. Those with diabetes who rely on this device for insulin management are most at risk.
Check for Omnipod DASH PDM devices with software version 1.0.50 or earlier. The product was sold in the US and EU with specific catalog numbers listed in the recall notice.
Look for the software version on your Omnipod DASH PDM device; versions 1.0.50 and earlier are affected.
Update to software version 1.0.51 or later to fix the issue, as provided by Insulet.
The Omnipod DASH PDM may suggest an inaccurate insulin dose if the blood glucose reading used is more than 10 minutes old and the user doesn't exit the bolus calculator as designed. This could lead to dangerous blood sugar levels.
Check your Omnipod DASH PDM software version; versions 1.0.50 and earlier are affected. The product was sold in the US and EU with specific catalog numbers listed in the recall notice.
Update to software version 1.0.51 or later to fix the issue. Insulet provides updates for affected devices.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-1553-2020 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-1553-2020 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.
