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

ICU Medical, Inc.: IV Sets with drip chambers

Is my product affected?

IV Sets with drip chambers

  • UPC 10840619000025
  • UPC 10840619000049
  • UPC 10840619004481
  • UPC 10840619004498
  • UPC 10840619004627
  • UPC 10840619099371
  • UPC 10887709095981
  • UPC 10887709093864
  • UPC 10087219126704
  • UPC 10840619060081
  • UPC 10887709070124
  • UPC 10887709123516
  • UPC 10887709124643
  • UPC 10887709090696
  • UPC 10887709124414
  • UPC 10887709066318
  • UPC 10887709089812
  • UPC 10887709090702
  • UPC 10887709120171
  • UPC 10887709120188
  • UPC 10887709122892
  • UPC 10887709122441
  • UPC 10887709123905
  • UPC 10887709124537
  • UPC 10887709126739
  • UPC 10887709095240
  • UPC 10887709095707
  • UPC 10887709124018
  • UPC 10887709085432
  • UPC 10887709086002
  • UPC 10887709088495
  • UPC 10887709088501
  • UPC 10887709088518
  • UPC 10887709089393
  • UPC 10887709089904
  • UPC 10887709091754
  • UPC 10887709091990
  • UPC 10887709095271
  • UPC 10887709121147
  • UPC 10887709128221

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. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

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. The presence of discoloration and particulate matter in the fluid path has not been ruled out. 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: 56,553,672 Lot/code info: All products manufactured on or before 7/4/2026. UDI-DI:10840619000025 10840619000049 10840619004481 10840619004498 10840619004627 10840619099371 10887709095981 10887709093864 10087219126704 10840619060081 10887709070124 10887709123516 10887709124643 10887709090696 10887709124414 10887709066318 10887709089812 10887709090702 10887709120171 10887709120188 10887709122892 10887709122441 10887709123905 10887709124537 10887709126739 10887709095240 10887709095707 10887709124018 10887709085432 10887709086002 10887709088495 10887709088501 10887709088518 10887709089393 10887709089904 10887709091754 10887709091990 10887709095271 10887709121147 10887709128221 10887709003610 10887709003627 10887709003634 10887709003672 10887709003696 10887709003733 10887709003740 10887709003757 10887709003764 10887709051550 10887709050409 10887709003894 10887709003924 10887709003931 10887709003986 10887709003993 10887709084060 10887709004020 10887709004037 10887709055404 10887709004075 10887709004082 10887709074016 10887709004099 10887709004129 10887709004167 10887709004358 10887709004365 10887709004389 10887709004518 10887709004525 10887709004549 10887709004563 10887709004570 10887709004792 10887709004808 10887709004914 10887709055442 10887709055527 10887709055657 10887709068138 10887709064840 10887709004969 10887709004976 10840619045569 10887709004990 10887709005010 10840619045576 10840619045583 10887709005041 10887709005072 10887709005089 10887709005102 10887709005188 10887709005201 10887709005249 1088

Source

Official record: FDA (Device enforcement) ↗

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

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