ICU Medical IV tubing sets recalled for black specks in drip chambers
What this means
ICU Medical IV tubing sets with drip chambers may contain black specks. The specks appear to result from the plastic molding process and may include discolored PVC material in the drip chamber wall. Particulate matter in the fluid path has not been ruled out.
- Check your IV sets for the presence of black specks or discoloration in the drip chamber.
- If you have affected sets (manufactured on or before July 4, 2026), stop using them and contact your supplier or ICU Medical for guidance.
- Report any adverse events or injuries to ICU Medical or the FDA MedWatch program.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3162-2026More ICU Medical recalls
- FDA-Device2026-09-23ICU Medical CADD Yellow Medication Cassette Reservoir recalled for medication leakage risk
- FDA-Device2026-09-23ICU Medical IV Sets with drip chambers recalled for black specks in fluid path
- 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.