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Insulet Corporation

Insulet Corporation: 2 recalls listed since March 2026 across FDA; 2 rated high risk.

By year

  • 20262

By agency

  • FDA2

By category

  • Medical Device2

All recalls (2)

Omnipod 5 Pods, Omnipod DASH Pod, and Omnipod (Eros) Pod

Omnipod insulin pods may leak insulin due to cannula damage, causing under-delivery and high blood glucose.

High risk, FDA, , Device defect

Insulet Omnipod 5 Pods

Omnipod 5 Pods may have a tear causing insulin to leak inside, leading to under-delivery or cessation of insulin.

High risk, FDA, , Manufacturing problem
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