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.
What this means for you
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
Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- ModerateICU Medical Recalls Oncology Sets with Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls CADD Yellow Medication Cassette Reservoirs Due to Leakage
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Same hazard · particulate matter
See all →- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- CriticalAmerican Regent Recalls Epinephrine Vials Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- CriticalB. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
Similar recalls
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls I.V. Infusion Sets with Potential Leak
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls ChemLock I.V. Infusion Administration Sets
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk
FDA (Devices) · 2016-04-06
- HighICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk
FDA (Devices) · 2019-10-23
- HighICU Medical Trifuse Extension Set Recalled for Connector Housing Gap
FDA (Devices) · 2022-09-21