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ICU Medical resolves Smiths Medical warning letter, posts mixed Q4

February 20, 2026 By Sean Whooley

This is the logo of ICU Medical.

ICU Medical (Nasdaq:ICUI) shares dipped slightly today on fourth-quarter results that were mixed compared to the consensus forecast.

Shares of ICUI fell 1.25% to $149.74 apiece in early-morning trading today.

The San Clemente, California-based infusion technology and critical care product provider reported losses of $15.7 million. That equals 64¢ per share on sales of $540.7 million for the three months ended Dec. 31.2025.

ICU Medical recorded a 34% bottom-line gain despite a sales decrease of 14.1%.

Adjusted to exclude one-time items, earnings per share came in at $1.91. That landed 22¢ ahead of expectations on Wall Street. Sales, however, came up just shy of estimates, as experts projected $541.2 million in revenue.

“Fourth quarter results were generally in line with our expectations,” ICU Medical CEO Vivek Jain said.

ICU Medical expects full-year GAAP net earnings between $26 million and $44 million. It projects adjusted EBITDA between $400 million and $430 million for 2026, with adjusted EPS set to land between $7.75 and $8.45.

The company said on its earnings call that management closed a broad FDA warning letter related to its Smiths Medical business. That letter came years ago, just before ICU Medical completed its acquisition of Smiths.

It received another letter in April 2025 and later faced multiple recalls for infusion pumps, including one in June and another in August.

ICU Medical also largely completed major manufacturing and ERP integrations while it also pursues FDA clearances for new pumps and its LifeShield software. Jain said this work could prove important as it addresses the primary concern of that 2025 warning letter.

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), MassDevice Earnings Roundup, Wall Street Beat Tagged With: ICU Medical, Smiths Medical

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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