ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
ICU Medical is recalling 28,550 oncology sets because drip chambers may contain black specks from the molding process. The discolored material does not enter the fluid path but may cause therapy delays.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a cosmetic defect (discolored PVC) that does not enter the fluid path, posing a risk of therapy delay rather than direct physical injury, which aligns with the Moderate severity criteria for minor defects or low-risk issues.
Plain-English summary
ICU Medical, Inc. is recalling 28,550 units of oncology sets with drip chambers. The recall covers products manufactured on or before July 4, 2026, with UDI-DI codes 10887709076768 and 10887709088105. These products were distributed nationwide in the United States and in specific countries including Pakistan, the Philippines, Malaysia, Hong Kong, India, Germany, and Costa Rica.
The recall was initiated because the drip chambers of the intravascular administration tubing sets may contain black specks. This discoloration is potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The source text explicitly states that this material does not enter the fluid path.
The primary risk associated with this defect is that if a healthcare provider sees the black specks, they may replace the product before use. This action could result in a delay in therapy for the patient. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Oncology sets with drip chambers
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 28,550
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All products manufactured on or before 7/4/2026. UDI-DI: 10887709076768
- 10887709088105
Distribution
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