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

Yes. Argus HQ has recorded 16 total FDA actions tied to ICU Medical, Inc.: 0 warning letters, 16 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 2026-09-23; Argus observed and indexed it on 2026-09-29.

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: IV Sets with drip chambers

Name: FDA Recall Record — ICU Medical, Inc.
Creator: Argus HQ
Published: 2026-09-23
License: https://argushq.ai/methodology

Event date: 2026-09-23 00:00:00Z
Observed: 2026-09-29 04:20:31Z
Source ID: Z-3160-2026
Payload hash: c0b254a3c3f6d0432aa2651d…

Summary

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out. 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 16 total FDA actions tied to ICU Medical, Inc.: 0 warning letters, 16 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 2026-09-23; Argus observed and indexed it on 2026-09-29.
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: IV Sets with drip chambers. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-icu-medical-inc-z-3160-2026

MLA

"ICU Medical, Inc. — Class II recall: IV Sets with drip chambers." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-icu-medical-inc-z-3160-2026.

Chicago

Argus HQ Research. "ICU Medical, Inc. — Class II recall: IV Sets with drip chambers." Digital Empire Holdings LLC. Accessed September 29, 2026. https://argushq.ai/events/fda-recall-icu-medical-inc-z-3160-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_icu_medical_inc_z_3160_2026_2026,
  title = {ICU Medical, Inc. — Class II recall: IV Sets with drip chambers},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-icu-medical-inc-z-3160-2026},
  note = {Accessed: September 29, 2026}
}

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