FDA recall record · openFDA

Insulet Corporation

5 FDA recalls on record (2023–2026) — 5 device. 5 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in in 1

The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. Thi 1

An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users 1

The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify 1

Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as 1

Recalls

Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7 Class I 2026-03-12 Omnipod 5 App (on compatible Android smartphones), Software Versions 1.1 - 1.2.3 (current). US: PT-000599- Omnipod 5 Ap Class I 2023-11-30 The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify Class II 2025-09-11 Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version Class II 2025-05-23 Omnipod 5 Automated Insulin Delivery System Class II 2023-02-28

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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