IV Sets Recall: ICU Medical Oncology sets with drip chambers
Intravascular administration tubing set drip chambers may have black specks due to the plastic molding process leaving discolored PVC material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out. The recall covers all products manufactured on or before 7/4/2026 and has worldwide distribution.
| Brand | ICU Medical, Inc. |
|---|---|
| Product | IV Sets with drip chambers |
| Reason | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out. |
| Severity | moderate |
| Units affected | 28550 |
| Distribution | Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use affected oncology sets with drip chambers.
- Contact ICU Medical, Inc. for replacement or return instructions and provide any available lot/UDI information.
- Consult your healthcare provider if you have used these sets and have concerns.
How to identify the recalled item
| Lot / date codes | All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831 |
|---|---|
| Lot / date codes | All products manufactured on or before 7/4/2026. UDI-DI: 10887709076768, 10887709088105 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.