The company identified a manufacturing issue through ongoing product monitoring that could result in insulin under-delivery with the affected current-generation Omnipod 5, previous-generation Omnipod Dash or the prior Omnipod Insulin Management System (Eros).
Insulet said the scope of this action reaches approximately 7 million pods. The company instructs users to identify affected devices and discontinue use.
This issue is separate from the March recall that affected certain Omnipod 5 lots. The FDA identified that recall as its most serious type last month, with 476 medical device reports, 29 serious injuries and no deaths associated with the previous issue. Insulet said it includes certain lots of devices distributed in the U.S. and affected international markets. Pods not included in the affected lots remain safe to use.
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