FDA Publicizes Communication from ICU Medical About Contamination of IV Tubing

Users are to inspect all IV tubing sets for any evidence of compromise, including black specks and discoloration on the inner wall of drip chambers.

Matt MacKenzie

May 28, 2026

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Key Highlights

Inspect all IV tubing sets for signs of compromise, including black specks, particulate matter, and condensation.
Segregate any tubing with anomalies and complete a MedWatch complaint to report issues.
Contact ICU Medical to return suspicious samples for further investigation.
ICU Medical is investigating whether observed discoloration and particulate matter indicate biological contamination.
The FDA emphasizes the importance of vigilance to ensure patient safety with IV therapy equipment.

The FDA is publicizing a customer communication from ICU Medical that recommends “certain IV tubing sets be removed from where they are used or sold.”

Users should “inspect all IV tubing sets for any evidence of compromise” and “segregate any items with anomalies, complete a MedWatch complaint, and contact ICU Medical to return the sample for investigation.” Specifically, users should look for “any evidence of compromise, including but not limited to marks or black specks on the chamber walls, particulate matter within the drip chamber or fluid path, and condensation within the device.”

ICU Medical has “received reports of black specks and discoloration observed on the inner wall of drip chambers, as well as particulate matter found within the drip chambers in certain IV tubing sets. ICU Medical stated that they are conducting an investigation to assess whether these findings represent biological contamination or could enter the fluid path and pose a risk to patients.”

IV tubing sets are tubes that “connect to IV fluid or medication bags and deliver fluids, medications, or blood into a patient’s vain.”