Levi & Korsinsky notifies investors that it has commenced an investigation into ICU Medical, Inc. (NASDAQ: ICUI) concerning potential violations of the federal securities laws.
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.
If you suffered a loss on your ICU Medical, Inc. securities and would like to explore a potential recovery under the federal securities laws, submit to us or contact Joseph E. Levi, Esq. via email at [email protected] or call 212-363-7500 to speak to our team of experienced shareholder advocates.
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