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 risk-of-harm product (medical device) where the presence of particulate matter in the fluid path has not been ruled out, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 86,113 units of IV Sets with drip chambers. The recall affects products manufactured on or before July 4, 2026, identified by UDI-DI 20887787005831.
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.
The affected products were distributed worldwide, including nationwide in the United States and in specific countries such as Pakistan, the Philippines, Malaysia, and Germany. Healthcare providers and consumers should stop using these specific IV sets and contact ICU Medical for instructions on replacement or return.
The recalled product
- Product
- IV Sets with drip chambers
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 86,113
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 (1)
- All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831
Distribution
Related recalls
Same manufacturer · ICU Medical, Inc.
See all →- 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 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 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
- HighICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
- CriticalB. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16