ICU Medical Recalls Oncology Sets with Drip Chamber Discoloration
ICU Medical is recalling 107,800 oncology sets because drip chambers may contain black specks from the molding process, which could lead to product replacement and 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 (discoloration) 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 issues or voluntary precautionary actions.
Plain-English summary
ICU Medical, Inc. is recalling 107,800 units of oncology sets with drip chambers. The recall covers products manufactured on or before July 4, 2026, with UDI-DI codes 10840619054486 and 10887709091914. The products were distributed worldwide, including nationwide in the United States and in specific countries such as Pakistan, the Philippines, Malaysia, and Germany.
The recall was initiated because the drip chambers of the intravascular administration tubing sets may contain black specks. These specks are potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The source text notes that this material does not enter the fluid path.
Healthcare providers who observe these specks may choose to replace the product before use. This action could result in a delay in therapy for patients. No illnesses or injuries are reported in the source text.
The recalled product
- Product
- Oncology sets with drip chambers
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Infusion Sets
- Affected units
- 107,800
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: 10840619054486
- 10887709091914
Distribution
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