Has ICU Medical, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 7 total FDA actions tied to ICU Medical, Inc.: 0 warning letters, 7 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 high severity by Argus HQ. FDA published the underlying record on 2026-06-17; Argus observed and indexed it on 2026-07-09.

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 · high

ICU Medical, Inc. — Class II recall: Plum Solo Precision IV Pump, 40001-0401

Name: FDA Recall Record — ICU Medical, Inc.
Creator: Argus HQ
Published: 2026-06-17
License: https://argushq.ai/methodology

Event date: 2026-06-17 00:00:00Z
Observed: 2026-07-09 22:52:16Z
Source ID: Z-2311-2026
Payload hash: fb8a55e9818b3c57c9182ea4…

Summary

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. Status: Ongoing.

Entities

ICU Medical, Inc.

View source record ↗

Frequently asked questions

Has ICU Medical, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 7 total FDA actions tied to ICU Medical, Inc.: 0 warning letters, 7 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 high severity by Argus HQ. FDA published the underlying record on 2026-06-17; Argus observed and indexed it on 2026-07-09.
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). ICU Medical, Inc. — Class II recall: Plum Solo Precision IV Pump, 40001-0401. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-icu-medical-inc-z-2311-2026

MLA

"ICU Medical, Inc. — Class II recall: Plum Solo Precision IV Pump, 40001-0401." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-icu-medical-inc-z-2311-2026.

Chicago

Argus HQ Research. "ICU Medical, Inc. — Class II recall: Plum Solo Precision IV Pump, 40001-0401." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-icu-medical-inc-z-2311-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_icu_medical_inc_z_2311_2026_2026,
  title = {ICU Medical, Inc. — Class II recall: Plum Solo Precision IV Pump, 40001-0401},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-icu-medical-inc-z-2311-2026},
  note = {Accessed: August 27, 2026}
}

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