ICU Medical, Inc. recalls IV Non-Dedicated Gravity Administration Sets with drip chambers

Recalling company

ICU Medical, Inc.

Product

IV Non-Dedicated Gravity Administration 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 that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

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

2,450

Lot / codes

All products manufactured on or before 7/4/2026. UDI-DI: 10887709079363 10887709079370 10887709079417 10887709079431 10887709079448 10887709079455 10887709097473 10887709079493 10887709079509 10887709079547

Company location

San Clemente, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-3157-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-3157-2026 in the FDA Enforcement Report. Also see FDA recall press releases.