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FDA RECALL ALERT

Omnipod Insulin Delivery Pods

Insulet is recalling Omnipod insulin delivery pods due to a manufacturing issue that may result in the under-delivery of insulin.

What to do

Contact Insulet Product Support at 1-800-641-2049 for further instructions regarding your device.

Posted
2026-05-26
Agency
Firm
Insulet
Status
ONGOING

Why it was recalled

Insulet is recalling certain Omnipod insulin delivery pods due to a manufacturing issue that may cause the device to deliver less insulin than intended. This under-delivery of insulin can lead to hyperglycemia or diabetic ketoacidosis.

How to identify it

Omnipod Device intended for the subcutaneous delivery of insulin into a patient

Editorial summary by Recall Canary · last updated 2026-05-26 · primary source: U.S. Food and Drug Administration