How many FDA actions has Philips Respironics, Inc. had?

Argus HQ has recorded 50 FDA events for Philips Respironics, Inc.: 0 warning letters, 50 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

What is the most recent FDA action against Philips Respironics, Inc.?

The most recent FDA event Argus HQ has on file for Philips Respironics, Inc. is dated 2026-04-08, 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 Philips Respironics, Inc. 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 Philips Respironics, Inc. is observed, this page's event count and history update automatically.

How many FDA actions does Argus HQ track for Philips Respironics, Inc.?

50 total: 0 warning letters, 50 recalls, 0 approval records, and 0 Form 483 inspection citations.

Philips Respironics, Inc. — FDA Enforcement History

FDA action counts

Total FDA actions	50
Warning letters	0
Recalls	50
Approval records	0
Form 483 inspection citations	0
Most recent action	April 8, 2026

The short version: Argus HQ has recorded 50 FDA events for Philips Respironics, Inc.: 0 warning letters, 50 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2023-01-18 to 2026-04-08. 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.

Enforcement history

On 2026-04-08, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-…. On 2026-04-08, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-us…. On 2026-04-08, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home…. On 2026-04-08, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuo…. On 2026-04-01, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuo…. On 2026-04-01, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: Philips Respironics Trilogy EV300, Software Version 1.05.15.00. Continuous home-…. On 2026-04-01, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-us…. On 2026-04-01, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home…. On 2025-11-19, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "high" severity in Argus HQ's classification: Philips Respironics, Inc. — Class II recall: SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected bat…. On 2025-08-20, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: DreamStation Auto BiPAP. Non-Continuous Ventilator.. On 2025-08-20, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: DreamStation Auto CPAP. Non-Continuous Ventilator.. On 2025-08-20, Argus HQ recorded an FDA recall for Philips Respironics, Inc., rated "critical" severity in Argus HQ's classification: Philips Respironics, Inc. — Class I recall: DreamStation Auto. Non-Continuous Ventilator..

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Philips Respironics, Inc. has 50 separate FDA recalls on file, more than a single isolated recall event. 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.

Frequently asked questions

How many FDA actions has Philips Respironics, Inc. had?: Argus HQ has recorded 50 FDA events for Philips Respironics, Inc.: 0 warning letters, 50 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.
What is the most recent FDA action against Philips Respironics, Inc.?: The most recent FDA event Argus HQ has on file for Philips Respironics, Inc. is dated 2026-04-08, 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 Philips Respironics, Inc. 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 Philips Respironics, Inc. is observed, this page's event count and history update automatically.
How many FDA actions does Argus HQ track for Philips Respironics, Inc.?: 50 total: 0 warning letters, 50 recalls, 0 approval records, and 0 Form 483 inspection citations.

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

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

Cite this record

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

APA

Argus HQ Research (2026). Philips Respironics, Inc. — FDA Enforcement History. Digital Empire LLC. Retrieved from https://argushq.ai/company/philips-respironics-inc

MLA

"Philips Respironics, Inc. — FDA Enforcement History." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/philips-respironics-inc.

Chicago

Argus HQ Research. "Philips Respironics, Inc. — FDA Enforcement History." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/company/philips-respironics-inc.

BibTeX

@misc{argushq_argushq_ai_company_philips_respironics_inc_2026,
  title = {Philips Respironics, Inc. — FDA Enforcement History},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/philips-respironics-inc},
  note = {Accessed: July 17, 2026}
}

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