ICU Medical Closes FDA Warning Letter, Posts Mixed Q4 and Sets 2026 Targets

Overview

• ICU Medical reported fourth-quarter 2025 revenue of $536 million with 2% organic growth, adjusted EBITDA of $98 million, adjusted EPS of $1.91, and an adjusted gross margin of about 40.5%.
• The company recorded a GAAP net loss of $15.7 million for the quarter even as adjusted earnings topped Wall Street expectations by 22 cents per share.
• Management said a broad FDA warning letter tied to the Smiths Medical acquisition has been closed, with major manufacturing and ERP integrations largely completed.
• The company is pursuing 510(k) clearances for key infusion pumps and its LifeShield software as it works to finalize regulatory and product initiatives.
• 2026 guidance calls for low- to mid-single-digit organic growth, adjusted EBITDA of $400–430 million, adjusted EPS of $7.75–8.45, gross margin near 41%, and a focus on free cash flow to reduce net leverage toward about 2x by early 2027; shares dipped 1.25% after the update.