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¿ Recalled by Insulet Corporation Due to Pod's needle mechanism fails to deploy or there...
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 (OUS) Catalog Number: 14810 Product Usage: The OmnniPod¿ Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.
Quantity: 5,179.0 boxes
Why Was This Recalled?
Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
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