company
ICU Medical, Inc.
Jurisdiction: US
FDA Warning Letter timeline
V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.
- fda_recall · device_recall2026-06-17ICU Medical, Inc. — Class II recall: Plum Duo Infusion Pump, 40002-0401
- fda_recall · device_recall2026-06-17ICU Medical, Inc. — Class II recall: Plum Duo Precision IV Pump, 40002-0403
- fda_recall · device_recall2026-06-17ICU Medical, Inc. — Class II recall: Plum Solo Precision IV Pump, 40001-0401
- fda_recall · device_recall2026-05-27ICU Medical, Inc. — Class II recall: Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Cla…
Frequently asked questions
- How many FDA warning letters has ICU Medical, Inc. received?
- Argus HQ has not recorded an FDA warning letter for ICU Medical, Inc. in our current dataset.
- What FDA recalls has ICU Medical, Inc. issued?
- Argus HQ has recorded 4 FDA recalls tied to ICU Medical, Inc..
- Is ICU Medical, Inc. FDA compliant?
- Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 4 recalls, and 0 approval records for ICU Medical, Inc.. Review the linked FDA source records directly before drawing a compliance conclusion.
Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.