Is this FDA enforcement data for ICU Medical, Inc. official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has ICU Medical, Inc. had?

Argus HQ has recorded 4 FDA events for ICU Medical, Inc.: 0 warning letters, 4 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 ICU Medical, Inc.?

The most recent FDA event Argus HQ has on file for ICU Medical, Inc. is dated 2026-06-17, with a severity rating of "high" 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 ICU Medical, 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 ICU Medical, Inc. is observed, this page's event count and history update automatically.

Regulatory Record: ICU Medical, Inc.

FDA action counts

Total FDA actions	4
Warning letters	0
Recalls	4
Approval records	0
Form 483 inspection citations	0
Most recent action	June 17, 2026

The short version: Argus HQ has recorded 4 FDA events for ICU Medical, Inc.: 0 warning letters, 4 recalls, 0 approvals, and 0 inspection 483 observations. These events span from 2026-05-27 to 2026-06-17. The most severe rating Argus HQ has assigned across this history is "high". 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 2026-05-27, Argus HQ recorded a FDA recall for ICU Medical, Inc., rated "high" severity in Argus HQ's classification: ICU Medical, Inc. — Class II recall: Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Cla… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for ICU Medical, Inc., rated "high" severity in Argus HQ's classification: ICU Medical, Inc. — Class II recall: Plum Duo Infusion Pump, 40002-0401 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for ICU Medical, Inc., rated "high" severity in Argus HQ's classification: ICU Medical, Inc. — Class II recall: Plum Duo Precision IV Pump, 40002-0403 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-06-17, Argus HQ recorded a FDA recall for ICU Medical, Inc., rated "high" severity in Argus HQ's classification: ICU Medical, Inc. — Class II recall: Plum Solo Precision IV Pump, 40001-0401 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. In total, ICU Medical, Inc. has 4 FDA events on file with Argus HQ across the sources Argus HQ currently tracks (FDA Warning Letters, recalls, drug/biologic approvals, and Form 483 inspection observations).

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. ICU Medical, Inc. has 4 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.

Frequently asked questions

Is this FDA enforcement data for ICU Medical, Inc. official?: Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.
How many FDA actions has ICU Medical, Inc. had?: Argus HQ has recorded 4 FDA events for ICU Medical, Inc.: 0 warning letters, 4 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 ICU Medical, Inc.?: The most recent FDA event Argus HQ has on file for ICU Medical, Inc. is dated 2026-06-17, with a severity rating of "high" 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 ICU Medical, 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 ICU Medical, Inc. is observed, this page's event count and history update automatically.

Every FDA action tied to this company, the week it happens.

Free weekly briefing. Real-time alerts on paid plans.

Compare with

Two different companies merged onto this page by mistake? Or a name variant missing? Tell us — corrections@argushq.ai

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). Regulatory Record: ICU Medical, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/company/icu-medical-inc

MLA

"Regulatory Record: ICU Medical, Inc.." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/company/icu-medical-inc.

Chicago

Argus HQ Research. "Regulatory Record: ICU Medical, Inc.." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/company/icu-medical-inc.

BibTeX

@misc{argushq_argushq_ai_company_icu_medical_inc_2026,
  title = {Regulatory Record: ICU Medical, Inc.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/company/icu-medical-inc},
  note = {Accessed: July 13, 2026}
}

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