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

Yes. Argus HQ has recorded 6 total FDA actions tied to ICU Medical, Inc.: 0 warning letters, 6 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 2026-07-22; Argus observed and indexed it on 2026-07-28.

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: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion…

Name: FDA Recall Record — ICU Medical, Inc.
Creator: Argus HQ
Published: 2026-07-22
License: https://argushq.ai/methodology

Event date: 2026-07-22 00:00:00Z
Observed: 2026-07-28 04:20:57Z
Source ID: Z-2724-2026
Payload hash: cc8f48b3980694112a85ec6b…

Summary

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. 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 6 total FDA actions tied to ICU Medical, Inc.: 0 warning letters, 6 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 2026-07-22; Argus observed and indexed it on 2026-07-28.
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: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-icu-medical-inc-z-2724-2026

MLA

"ICU Medical, Inc. — Class II recall: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-icu-medical-inc-z-2724-2026.

Chicago

Argus HQ Research. "ICU Medical, Inc. — Class II recall: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion…." Digital Empire Holdings LLC. Accessed July 28, 2026. https://argushq.ai/events/fda-recall-icu-medical-inc-z-2724-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_icu_medical_inc_z_2724_2026_2026,
  title = {ICU Medical, Inc. — Class II recall: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-icu-medical-inc-z-2724-2026},
  note = {Accessed: July 28, 2026}
}

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