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Insulet Corporation: Omnipod 5

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer

Recall reason: The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recognize the error on the bolus calculator screen or the confirmation screen prior to starting the bolus.. Recalled by Insulet Corporation. Distribution: Worldwide distribution - US Nationwide and the countries of Germany and UK.. Classification (Class I — serious health hazard). Affected lots/dates: UDI/Model/NDC Number: " Omnipod 5 App Software UDI: 1038508112030 " EU locked-down Controller UDI: 10385083000190 and 10. Contact the manufacturer or the retailer where you purchased thi

Reward FDA device recall — free correction, repair, or replacement from manufacturer or authorized retailer
Category Product Recalls & Refunds
Location National
Eligibility U.S. consumers who own or purchased the recalled medical device. Contact the manufacturer or the retailer/pharmacy where you purchased it to arrange for a free correction, repair, or replacement. Have the model number ready if possible.
Source Official Source ↗
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