FDAFDA · Food and drugs·Recall number Z-3162-2026
IV Sets with drip chambers
Published September 23, 2026 · Recall initiated: May 12, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- 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.
- Lot
- All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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