Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Recalled by Insulet Corporation Due to OmniPods¿ (Pods) have a higher rate of failure...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Insulet Corporation directly.
Affected Products
OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Quantity: 24829 boxes Expanded: 26,230.9 boxes
Why Was This Recalled?
OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Insulet Corporation
Insulet Corporation has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report