Gross Contamination of Intravenous Tubing Sets Alert

Key points

• The Centers for Disease Control and Prevention (CDC) has been notified of multiple health care facilities in Maine and Pennsylvania reporting visible contamination of intravenous (IV) tubing (small black dots on the internal walls of the drip chambers) from the same manufacturer, ICU Medical.
• At this time, no adverse events or patient infections have been linked with the contaminated product.
• Health care facilities should check IV tubing supplies to see if they are manufactured by ICU Medical. If so, physically inspect supplies to assess for any visible contamination as soon as possible. If visible contamination is identified, health care facilities should sequester the affected products, immediately alert ICU Medical, and file a Food and Drug Administration (FDA) MedWatch report.

Background

On May 8, 2026, the Maine Center for Disease Control and Prevention sent a Health Alert Network (HAN) to key individuals and organizations regarding an ongoing investigation of contaminated IV sets from ICU Medical.

Because this contamination affects very specific lots, facilities using IV tubing products should determine if they currently have any lots on hand. The lot numbers as well as other information about the recall can be found in the Health Alert Network (HAN) from the Maine Center for Disease Control and Prevention. If contamination is found, the organization should contact ICU Medical and file an FDA MedWatch report.