← Search recalls
FDA (Device enforcement)Recalled 2026-05-12class ii

ICU Medical, Inc.: Oncology sets with drip chambers

Is my product affected?

Oncology sets with drip chambers

  • UPC 10887709076768
  • UPC 10887709088105

Check against the official notice below — it lists the full affected range.

Hazard

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.

Details from the source

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. 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. Quantity: 28,550 Lot/code info: All products manufactured on or before 7/4/2026. UDI-DI: 10887709076768, 10887709088105

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

All FDA (Device enforcement) recalls

Hurt by this product? Start a free Case Check

ProductRisk is not a law firm and does not provide legal services or legal advice. ProductRisk is a free consumer product-safety information service operated by Plaintify, Inc., a technology company. If you ask to be connected with a law firm, any legal services are provided by that firm — not by ProductRisk or Plaintify.

Privacy · Plaintify