Omnipod 5 Automated Insulin Delivery System Product catalog numbers:… — Class II medical device recall Z-0423-2023
Ongoing recall by Insulet Corporation, reported 2022-12-14, distributed nationwide. The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and cha
| Recall number | Z-0423-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Insulet Corporation, Acton, MA, United States |
| Recall initiated | 2022-11-14 |
| Classified | 2022-12-07 |
| Reported by FDA | 2022-12-14 |
| Distributed | Nationwide (US) |
| Quantity | 129,086 |
| Reason classes | device malfunction |
| Model numbers | PT-000409 |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0423-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.