- Recalling firm
- ICU Medical, Inc.
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- All products manufactured on or before 7/4/2026. UDI-DI: 20887787005831
- Units affected
- 86,113
- Distribution pattern
- 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.
- Firm location
- San Clemente, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Press Release
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3162-2026
- Recall initiated
- May 12, 2026
- FDA classification date
- September 11, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99058
- Last updated on HTM Vibe
- September 29, 2026