Omnipod 5 Automated Insulin Delivery System
Insulet Corporation · Insulin pumps
Active recall recordLast checked Oct 8, 2026
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MedWatcher tracks the reviewed device families Omnipod 5 Automated Insulin Delivery System, Omnipod DASH Insulin Management System under the canonical manufacturer identity Insulet Corporation. The recall records on this page are limited to 5 owner-approved FDA recall actions.
This page covers only the reviewed device families and FDA recall actions shown below. It is not a complete product catalogue, and a recall does not necessarily affect every unit or configuration in a device family.
The manufacturer and device-family relationships come from the reviewed canonical-device inventory. Recall coverage is limited to the exact candidate IDs approved and published in the FUS-265 cohort; complete regulator payloads remain in the private source ledger.
Source databases can use a legal name, brand, division, or shortened name. MedWatcher retains the form used as evidence rather than treating every similar name as the same manufacturer.
Page reviewed Aug 17, 2026 by fusiondesigner@gmail.com · Next review by Nov 17, 2026.
Insulet Corporation · Insulin pumps
Active recall recordLast checked Oct 8, 2026
Insulet Corporation · Insulin pumps
Active recall recordLast checked Oct 8, 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…