What ICU Medical, Inc. told the SEC could break it.

ICU Medical depends heavily on one distributor: worldwide net sales to a single distributor were 18% of consolidated net sales in both 2025 and 2024 (16% in 2023). Because it relies on key distributors to reach healthcare providers, loss of this distributor — or its financial distress/bankruptcy — could materially reduce revenue and impair collections.

“In 2025, 2024, and 2023, we had worldwide net sales to a single distributor of 18%, 18%, and 16% of consolidated net sales, respectively.”

A significant portion of ICU Medical's revenue comes from goods manufactured in Costa Rica and Mexico (Ensenada) and imported into the U.S., exposing it to escalating U.S. tariffs. As of July 31, 2025 the baseline reciprocal tariff was raised to 15% for certain countries including Costa Rica; most products from its Mexico facilities are currently exempt under USMCA, but if those USMCA exemptions were eliminated, its tariff expense on Mexico-made products would increase substantially. Retaliatory tariffs from Canada, China and Mexico add further pressure.

“on July 31, 2025, the U.S. announced that the 10% baseline reciprocal tariff on imports from all countries would be raised to 15% for certain countries, including Costa Rica. As to the majority of products manufactured in our Mexico facilities, these are currently exempted from tariffs under the United States-Mexico-Canada Agreement ("USMCA"). If, however, the USMCA exemptions were eliminated in the future, our tariff expense for products manufactured in Mexico would increase substantially.”

ICU Medical relies on a single-source supplier for certain materials — such as resins — that are critical to manufacturing its products, and certain other components/raw materials are available only from a single supplier. A supply interruption in limited- or sole-sourced raw materials could materially harm its ability to manufacture until a new source is identified and qualified, a process that can take considerable time given medical-device quality requirements.

“We currently rely on a single source supplier for the supply of certain materials (such as resins) that are critical to our ability to manufacture our products.”

ICU Medical manufactures its Clave products (needlefree connectors, a core product line) at a single facility in Salt Lake City, Utah, which also produces other components on which its Ensenada, Mexico and Costa Rica manufacturing operations rely. A disruption at this single site (as occurred when COVID-19 forced temporary shutdowns in 2021) would cascade across its broader manufacturing network — a concentrated single-point-of-failure in its production base.

“We have a single manufacturing facility for our Clave products located in Salt Lake City, Utah. Our Salt Lake City facility also produces other components on which our manufacturing operations in Ensenada, Mexico and Costa Rica rely.”