Device SafetyConfirmed
FDA Flagged a Serious Omnipod Insulin-Delivery Recall
Certain Omnipod Pods may leak insulin because of a cannula tear, creating under-delivery risk that can lead to hyperglycemia or diabetic ketoacidosis.
Why now
FDA's Class I classification makes this an urgent patient-safety story for insulin-dependent diabetes users who may have affected Pods.
- Overclaim risk
- high
- Primary source
- Official
- Published
- Jul 5, 2026