FDA-Device2026-09-23Class IIPROCESSING DEFECT
ICU Medical IV Sets with drip chambers recalled for black specks in fluid path
What this means
ICU Medical IV tubing sets may contain black specks in the drip chamber, caused by discolored plastic material left behind during manufacturing. Particulate matter in the fluid path has not been ruled out.
- Check your IV sets for the product codes listed in the recall (UDI-DI numbers ending in 25, 49, 4481, etc.)
- Do not use affected sets manufactured on or before July 4, 2026
- Contact your healthcare provider or ICU Medical for instructions on replacement or inspection
The agency's original wording
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.
Intended for
All ages
Illnesses reported
None reported
Sold states
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.
Affected count
56,553,672
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
Products
IV Sets with drip chambers
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3163-2026More ICU Medical recalls
- FDA-Device2026-09-23ICU Medical CADD Yellow Medication Cassette Reservoir recalled for medication leakage risk
- FDA-Device2026-09-23ICU Medical IV tubing sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical IV gravity administration sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical IV tubing sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical Plum administration sets recalled for black specks in drip chambers
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.