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ICU Medical: risk summary

Summaries are drawn from public sources and link to them. HSH does not give a risk rating: read the summary and sources and reach your own view. Unproven allegations are labelled as such. Suppliers can submit a response, which is shown alongside.

Financial

Latest full-year results from official filings.

FY2025 revenue $2.23bn (-6.3%); operating margin 1.9%; net income $0.7m.

Cash $308.0m; debt $1.28bn.

Researched 8 Nov 2026

Adverse media

Credible news about incidents, disputes, legal action or restructuring in the last 24 months.

May 2025: ICU Medical and Otsuka Pharmaceutical Factory completed formation of the Otsuka ICU Medical IV solutions joint venture for North America. Apr 2025: ICU Medical received an FDA warning letter (see regulatory).

Researched 10 Nov 2026

Cyber & information governance

Data breaches, cyber incidents, regulator action and assurance status.

No data breaches, cyber incidents, regulator action or published product security advisories involving ICU Medical found in HSH's search of the last 24 months. NHS DSPT status not yet checked.

Researched 10 Nov 2026

Regulatory & clinical safety

Recalls, safety notices, regulator action and clinical safety concerns.

Aug 2025: FDA classed a Plum Duo infusion pump software correction (pump may freeze, delaying therapy) as its most serious recall type; no injuries reported. Apr 2025: an FDA warning letter cited unapproved design changes to Medfusion 4000 and CADD Solis pumps.

Researched 10 Nov 2026

Contract performance

Contract delivery, go-lives, terminations and disputes.

No notable troubled implementations, terminations, customer disputes or significant NHS contracts involving ICU Medical found in HSH's search of the last 24 months.

Researched 10 Nov 2026