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 2026-07-29; Argus observed and indexed it on 2026-08-04.

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: Hotline Fluid Warming Set, single use device, is designed to warm blood and intr…

Name: FDA Recall Record — ICU Medical, Inc.
Creator: Argus HQ
Published: 2026-07-29
License: https://argushq.ai/methodology

Event date: 2026-07-29 00:00:00Z
Observed: 2026-08-04 04:20:51Z
Source ID: Z-2759-2026
Payload hash: 6c8222026161cb36e615e62e…

Summary

ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond. 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 2026-07-29; Argus observed and indexed it on 2026-08-04.
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: Hotline Fluid Warming Set, single use device, is designed to warm blood and intr…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-icu-medical-inc-z-2759-2026

MLA

"ICU Medical Inc. — Class II recall: Hotline Fluid Warming Set, single use device, is designed to warm blood and intr…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-icu-medical-inc-z-2759-2026.

Chicago

Argus HQ Research. "ICU Medical Inc. — Class II recall: Hotline Fluid Warming Set, single use device, is designed to warm blood and intr…." Digital Empire Holdings LLC. Accessed August 4, 2026. https://argushq.ai/events/fda-recall-icu-medical-inc-z-2759-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_icu_medical_inc_z_2759_2026_2026,
  title = {ICU Medical Inc. — Class II recall: Hotline Fluid Warming Set, single use device, is designed to warm blood and intr…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-icu-medical-inc-z-2759-2026},
  note = {Accessed: August 4, 2026}
}

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