Insulet recalls Omnipod DASH insulin systems with specific lot numbers due to potential communication errors that could lead to inaccurate insulin readings. Affected users should contact Insulet for details.
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.
Insulet is recalling certain Omnipod DASH insulin management systems that may show inaccurate insulin levels after a bolus command. This could lead to incorrect insulin dosing if users rely on the system's readings.
The system may experience communication interruptions after a bolus command, causing inaccurate insulin on board (IOB) readings, last bolus field, or bolus history. This could lead to incorrect insulin dosing if users depend on these readings.
People using the Omnipod DASH insulin system with the listed lot numbers are affected. Those with diabetes who rely on the system for insulin management are most at risk.
Check your Omnipod DASH system's product catalog number (18239 M/D: PDM USA1 D001 MG USA1) and lot numbers (L000120 to L000136). The recall covers specific lot numbers listed in the official notice.
Identify your Omnipod DASH system's product catalog number and lot numbers to confirm if it's affected.
Lot numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, and L000136 are affected.
The recall does not mention a fix or remedy; affected users should contact Insulet for further instructions.
Inaccurate insulin readings could lead to incorrect insulin dosing if users rely on the system's data after a bolus command.
We’ve drafted a message you can send Insulet to request your refund or repair — edit it as you like.
Subject: Recall Z-0347-2020 — Insulet Insulet Hello, I own a Insulet that is covered by recall Z-0347-2020 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.
