What is the most recent FDA action against Insulet Corporation?

The most recent FDA event Argus HQ has on file for Insulet Corporation is dated 2026-04-22, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Does Argus HQ track new FDA actions for Insulet Corporation automatically?

Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Insulet Corporation is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Insulet Corporation?

4 total: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

What is the most recent FDA action on file for Insulet Corporation?

July 8, 2026. Argus HQ ingests new FDA enforcement records daily.

FDA Actions Against Insulet Corporation

At a glance: Argus HQ has recorded 1 FDA events for Insulet Corporation: 0 warning letters, 1 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-04-22 to 2026-04-22. The most severe rating Argus HQ has assigned across this history is "critical". Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

FDA action counts

Total FDA actions	4
Warning letters	0
Recalls	4
Approval records	0
Form 483 inspection citations	0
Most recent action	July 8, 2026

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Insulet Corporation has 1 FDA event on file. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ does not independently verify FDA's underlying findings; this page summarizes what FDA has published and links back to the original FDA source for each event. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Enforcement history

On 2026-04-22, Argus HQ recorded an FDA recall for Insulet Corporation, rated "critical" severity in Argus HQ's classification: Insulet Corporation — Class I recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Frequently asked questions

What is the most recent FDA action against Insulet Corporation?: The most recent FDA event Argus HQ has on file for Insulet Corporation is dated 2026-04-22, with a severity rating of "critical" in Argus HQ's classification. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
Does Argus HQ track new FDA actions for Insulet Corporation automatically?: Yes. Argus HQ ingests FDA sources daily, including FDA warning letters, recalls, drug and biologic approvals, and Form 483 inspection observations. When a new FDA action linked to Insulet Corporation is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for Insulet Corporation?: 4 total: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.
What is the most recent FDA action on file for Insulet Corporation?: July 8, 2026. Argus HQ ingests new FDA enforcement records daily.

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

Verified from FDA.gov · Last updated: Jul 8, 2026

Cite this record

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

APA

Argus HQ Research (2026). FDA Actions Against Insulet Corporation. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/company/insulet-corporation

MLA

"FDA Actions Against Insulet Corporation." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/company/insulet-corporation.

Chicago

Argus HQ Research. "FDA Actions Against Insulet Corporation." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/company/insulet-corporation.

BibTeX

@misc{argushq_argushq_ai_company_insulet_corporation_2026,
  title = {FDA Actions Against Insulet Corporation},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/company/insulet-corporation},
  note = {Accessed: August 27, 2026}
}

Source: FDA.gov (aggregated across Warning Letters, Recalls, Approvals, Form 483s) ↗