Class II — Insulet Corporation
| Recalling firm | INSULET CORPORATION |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | 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 |
| Distribution | Domestic distribution nationwide. |
| Initiated | 2022-11-14 |
| Classified | 2022-12-07 |
| Recall number | Z-0423-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Insulet Corporation (Z-0423-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91127/
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