How many FDA warning letters has Insulet Corporation received?

Argus HQ has not recorded an FDA warning letter for Insulet Corporation in our current dataset.

What FDA recalls has Insulet Corporation issued?

Argus HQ has recorded 1 FDA recall tied to Insulet Corporation.

Is Insulet Corporation FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 0 approval records for Insulet Corporation. Review the linked FDA source records directly before drawing a compliance conclusion.

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company

Insulet Corporation

Name: FDA Enforcement Actions Against Insulet Corporation
Creator: Argus HQ
License: https://argushq.ai/methodology

Jurisdiction: US

FDA Warning Letter timeline

V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.

fda_recall · device_recall2026-04-22
Insulet Corporation — Class I recall: Omnipod 5 Pods. Model/Catalog number: PT-001662 ASM 5PK Pod STRL OPS G6G7

Frequently asked questions

How many FDA warning letters has Insulet Corporation received?: Argus HQ has not recorded an FDA warning letter for Insulet Corporation in our current dataset.
What FDA recalls has Insulet Corporation issued?: Argus HQ has recorded 1 FDA recall tied to Insulet Corporation.
Is Insulet Corporation FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 1 recall, and 0 approval records for Insulet Corporation. Review the linked FDA source records directly before drawing a compliance conclusion.

Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.