Agency classClass IIOur severity:High FDA (Devices)·Z-0423-2023·Announced 2022-12-14

Omnipod 5 Controller charging port melting poses minor burn risk

Insulet is recalling Omnipod 5 Controllers where the charging port and cable may melt or deform from excessive heat, potentially causing minor burns if touched and preventing the device from charging.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving risk of minor thermal burns and device charging failure, with no reported illnesses or injuries. The hazard is potential rather than actual, consistent with the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Omnipod 5 Automated Insulin Delivery System Controller is being recalled by Insulet Corporation due to a charging port issue affecting 129,086 units distributed nationwide. The Controller's charging port and cable may melt, deform, or discolor as a result of excess heat generated by increased electrical resistance in the port.

This defect creates two potential hazards: the excess heat may cause minor burns if the charging equipment is touched by users, and the Controller may fail to charge entirely. If the Controller fails to charge, users are required to switch to their backup insulin plan.

Affected individuals should immediately stop using the current charging cable and port and contact Insulet for a replacement or alternative charging solution. No illnesses or injuries have been reported to date.

The recalled product

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
Manufacturer: Insulet Corporation
Category: Medical Device — Insulin Delivery System
Hazard: burn-injury
device-failure
heat-damage
Affected units: 129,086

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

ALL serial numbers/ controller lots are currently in scope of this recall

Distribution

Distributed nationwide across the United States.

Same manufacturer · Insulet Corporation

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