- 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 that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.
- Affected products (lot / model / serial)
- All products manufactured on or before 7/4/2026. UDI-DI: 10887709076768, 10887709088105
- Units affected
- 28,550
- 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-3159-2026
- 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