Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: Recalled by Insulet Corporation Due to The firm has become aware of an issue...
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 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
Quantity: 129,086
Why Was This Recalled?
The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan.
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