On April 22, 2025, ICU Medical disclosed it had received a warning letter from the FDA citing unauthorized changes to two of its infusion pump products. The warning letter stated that the pumps were "adulterated" and "misbranded" and noted the Company's modifications "can significantly impact the functionality of the device with respect to the infusion pumps delivery profile, alarm functionality. The FDA stated that these changes may have significantly impacted the safety and efficacy of the devices, raising concerns about the adequacy of ICU Medical’s regulatory disclosures.
Following this news, shares of ICU Medical, Inc. fell over 4% on the same day.
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