ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
ICU Medical is recalling IV sets with drip chambers due to potential black specks and particulate matter in the fluid path.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential risk of particulate matter in the fluid path, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 6,105,468 units of IV Sets with drip chambers. The recall covers all products manufactured on or before July 4, 2026, and includes specific UDI-DI codes listed in the agency record.
The recall was initiated because the drip chambers may contain black specks, potentially resulting from the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
The affected products were distributed worldwide, including nationwide in the United States and in specific countries such as Pakistan, the Philippines, Malaysia, Hong Kong, India, Germany, and Costa Rica. Healthcare facilities and consumers should stop using the affected IV sets and contact the manufacturer for further instructions.
The recalled product
- Product
- IV Sets with drip chambers
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — IV Sets
- Affected units
- 6,105,468
Distribution
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