ICU Medical, Inc.
FDA adverse event reports naming ICU Medical, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ICU MEDICAL, INC..
- Total reports
- 13,635
- Deaths
- 28
- Injuries
- 307
- Malfunctions
- 13,033
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Pump, InfusionFRN7,681
- Pump, Infusion, PcaMEA2,324
- Set, Administration, IntravascularFPA1,747
- Stopcock, I.V. SetFMG270
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ221
- Transducer, Blood-Pressure, ExtravascularDRS207
- Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer SystemONB146
- Tube Tracheostomy And Tube CuffJOH124
- Tubes, Vials, Systems, Serum Separators, Blood CollectionJKA105
- Warmer, Thermal, Infusion FluidLGZ98
Recent recalls
- 2026-09-17Open, ClassifiedProcess control
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24JP 21-7600-24JP 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.
- 2026-09-11Open, ClassifiedProcess control
Plum administration sets
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.
- 2026-09-11Open, ClassifiedProcess control
IV Non-Dedicated Gravity Administration Sets with drip chambers
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.
- 2026-09-11Open, ClassifiedProcess control
Oncology sets with drip chambers
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.
- 2026-09-11Open, ClassifiedProcess control
Oncology sets with drip chambers
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.
- 2026-09-11Open, ClassifiedProcess control
IV Sets with drip chambers
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.
- 2026-09-11Open, ClassifiedProcess control
IV Sets with drip chambers
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.
- 2026-09-11Open, ClassifiedProcess control
IV Sets with drip chambers
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.
- 2026-09-11Open, ClassifiedProcess control
IV Sets with drip chambers
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.
- 2026-07-17Open, ClassifiedProcess control
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond.
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