Recall company profile

Insulet Corporation Recalls

Overview of recall records associated with Insulet Corporation, including dates, categories and classifications where available.

4recall records
Jul 8, 2026latest record date
Apr 22, 2026earliest record date

Recall history in this database

Classification mix: Class I: 4.

Medical DeviceJul 8, 2026

Insulet Omnipod (Eros) Pod recall — FDA Z-2605-2026

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…

Class IFDA: OngoingInsulet Corporation
Medical DeviceApr 22, 2026

Insulet Omnipod 5 Pods recall — FDA Z-1797-2026

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…

Class IFDA: OngoingInsulet Corporation

Understanding this recall history

This page summarizes recall records in which the official source identifies Insulet Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.

Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.