ICU Medical IV gravity administration sets recalled for black specks in drip chambers
What this means
Some ICU Medical IV gravity administration sets contain black specks in the drip chamber wall caused by the plastic molding process. The specks do not enter the fluid path but may prompt healthcare providers to replace the tubing before use, potentially delaying patient therapy.
- Check affected IV sets (manufactured on or before July 4, 2026) for black specks in the drip chamber before use.
- If black specks are visible, do not use the set and obtain a replacement without delay.
- Contact your medical supplier or ICU Medical if you have questions about affected product lot numbers.
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 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3157-2026More ICU Medical recalls
- 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
- FDA-Device2026-09-23ICU Medical IV tubing sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical oncology IV tubing sets recalled for black specks in drip chambers
- FDA-Device2026-09-23ICU Medical oncology IV tubing sets recalled for black specks in drip chambers
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