Omnipod 5 Automated Insulin Delivery System
Insulet Corporation · Insulin pumps
Active recall recordLatest source check Oct 27, 2026
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Devices and FDA recall records listed on MedWatcher for Insulet Corporation.
This page covers the devices and recall records listed below, not the complete product catalogue or recall history. A recall may apply only to specific models, lots, or serial numbers.
Device and manufacturer names are linked using official product, UDI, or FDA records. The source links below show the supporting information.
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Insulet Corporation · Insulin pumps
Active recall recordLatest source check Oct 27, 2026
Insulet Corporation · Insulin pumps
Active recall recordLatest source check Oct 27, 2026
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode is pump under-delivery due to loss of insulin to an…
Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of basal or bolus delivery. This defect results from damage to…
The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes…
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if the user manually updates their phone…
An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which may cause a delay in therapy. To reduce the…