Class IIDeviceOngoing

ICU Medical, Inc.

IV Sets with drip chambers

Reason for recall

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.

Details

Recall number: Z-3163-2026
Event ID: 99058
Recall initiated: May 12, 2026
Classified: Sep 11, 2026
Reported: Sep 23, 2026
Quantity: 56,553,672
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.
Initiated by: Voluntary: Firm initiated
Firm notification: Press Release
Firm location: San Clemente, CA, United States
Lot / code info: All products manufactured on or before 7/4/2026. 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