IV Sets with drip chambers recall (ICU Medical, Inc.)
Medical deviceClass IIOngoing
Summary: ICU Medical, Inc. is recalling 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.
What is being recalled
IV Sets with drip chambers
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming)
How to tell if yours is affected
All products manufactured on or before 7/4/2026. UDI-DI: 10840619023307 10840619023338 10840619023369 10840619036468 10840619023963 10840619041288 10840619024007 10840619024809 10840619036796 10840619068278 10840619075993 10840619083431 10887709074726 10887709085913 10887709097176 10887709098340 10840619056480 10840619054783 10887709057019 10887709086415 10887709099958 10887709072920 10887709099590 10887709075181 10887709099965 10887709123042 10887709075051 10887709071404 10887709057026 10887709120010 10887709057033 10887709057040 10887709120027 10887709083322 10887709085098 10887709088808 10887709073798 10887709073804 10887709088860 10887709090641 10887709095530 10887709122861 10887709095776 10887709097466 10887709121284 10840619085046 10840619024076 10840619034037 10840619078048 10840619079427 10840619079434 10887709098333 10887709080055 10840619064928 10887709089126 10887709081410 10887709088686 10887709122748 10840619094994 10887709085869
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3161-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 12, 2026 |
| Reported | September 23, 2026 |
| Company | ICU Medical, Inc. |
| Company location | San Clemente, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 6,105,468 |
More recalls from ICU Medical, Inc. · all medical device recalls · recalls from May 2026