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 entering the fluid path, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling IV Sets with drip chambers. The recall affects approximately 100.7 million units distributed worldwide, including across the United States and several international territories.
The recall was initiated because the drip chambers may contain black specks, potentially caused by discolored polyvinyl chloride (PVC) material left in the chamber wall during the plastic molding process. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Healthcare facilities and consumers should stop using the affected IV sets and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- IV Sets with drip chambers
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 100,712,657
Distribution
Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- HighICU Medical Recalls CADD Yellow Medication Cassette Reservoirs Due to Leakage
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
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
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 →- SevereFDA Recalls Argatroban Injection Vials Due to Particulate Matter
FDA (Drugs) · 2026-10-28
- SeverePar Health Recalls Argatroban Injection Vials Due to Particulate Matter
FDA (Drugs) · 2026-10-28
- ModerateIMAAVY Injection Recalled for Presence of Particulate Matter
FDA (Drugs) · 2026-10-14
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Similar recalls
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls Oncology Sets with Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- ModerateICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
- HighICU Medical Recalls I.V. Infusion Sets with Potential Leak
FDA (Devices) · 2016-04-06