ICU Medical, Inc. recalls IV Sets with drip chambers

Recalling company

ICU Medical, Inc.

Product

IV Sets with drip chambers

Reason

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 12, 2026

Reported

Sep 23, 2026

Distribution

Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR.

Status

Ongoing

Quantity

86,113

Lot / codes

All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831

Company location

San Clemente, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-3162-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3162-2026 in the FDA Enforcement Report. Also see FDA recall press releases.