Has Insulet Corporation had other FDA enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Insulet Corporation: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · critical

Insulet Corporation — Class I recall: Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720.…

Name: FDA Recall Record — Insulet Corporation
Creator: Argus HQ
Published: 2026-07-08
License: https://argushq.ai/methodology

Event date: 2026-07-08 00:00:00Z
Observed: 2026-07-14 04:20:20Z
Source ID: Z-2603-2026
Payload hash: 8aba6268a3ffa46585843e52…

Summary

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 external leak. If insulin is not delivered prope… Status: Ongoing.

Entities

Insulet Corporation

View source record ↗

Frequently asked questions

Has Insulet Corporation had other FDA enforcement actions?: Yes. Argus HQ has recorded 4 total FDA actions tied to Insulet Corporation: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged critical severity by Argus HQ. FDA published the underlying record on 2026-07-08; Argus observed and indexed it on 2026-07-14.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Insulet Corporation — Class I recall: Omnipod 5 Pods. Includes the below Model/REF Numbers:     1. POD-OMNI-I1-6720.…. Digital Empire LLC. Retrieved from https://argushq.ai/events/fda-recall-insulet-corporation-z-2603-2026

MLA

"Insulet Corporation — Class I recall: Omnipod 5 Pods. Includes the below Model/REF Numbers:     1. POD-OMNI-I1-6720.…." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/events/fda-recall-insulet-corporation-z-2603-2026.

Chicago

Argus HQ Research. "Insulet Corporation — Class I recall: Omnipod 5 Pods. Includes the below Model/REF Numbers:     1. POD-OMNI-I1-6720.…." Digital Empire LLC. Accessed July 14, 2026. https://argushq.ai/events/fda-recall-insulet-corporation-z-2603-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_insulet_corporation_z_2603_2026_2026,
  title = {Insulet Corporation — Class I recall: Omnipod 5 Pods. Includes the below Model/REF Numbers:     1. POD-OMNI-I1-6720.…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/events/fda-recall-insulet-corporation-z-2603-2026},
  note = {Accessed: July 14, 2026}
}

Informational only. Not legal, financial, or medical advice.