Reported Dec 14, 2022 · Ongoing
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed…
Insulet Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Insulet Corporation · 100 Nagog Park · Acton, MA · 01720-3440
Is this the product you have?
- Omnipod 5 Automated Insulin
- Delivery System Product catalog numbers
PT-000409: ASMOmnipod 5PDM
- Programmed PT-000428Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM
- US PT-000429Cable, Charging, Omnipod 5, Horizon PDM
- Lot codes and dates
- ALL serial numbers/ controller lots are currently in scope of this recall
- Amount recalled
- 129,086
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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