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
- 1,150
- Deaths
- 1
- Injuries
- 22
- Malfunctions
- 1,121
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, InfusionFRN603
- Set, Administration, IntravascularFPA198
- Pump, Infusion, PcaMEA158
- Tube Tracheostomy And Tube CuffJOH18
- Warmer, Thermal, Infusion FluidLGZ17
- Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI16
- Transducer, Blood-Pressure, ExtravascularDRS16
- Warmer, Blood, Non-Electromagnetic RadiationBSB12
- Tube, Tracheostomy (W/Wo Connector)BTO11
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 DaysFOZ10
Recent recalls
- 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.
- 2026-07-10Open, ClassifiedUnder Investigation by firm
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
- 2026-07-10Open, ClassifiedUnder Investigation by firm
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
- 2026-06-05Open, ClassifiedSoftware Design Change
Plum Solo Precision IV Pump, 40001-0401
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
- 2026-06-05Open, ClassifiedSoftware Design Change
Plum Duo Infusion Pump, 40002-0401
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
- 2026-06-05Open, ClassifiedSoftware Design Change
Plum Duo Precision IV Pump, 40002-0403
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
- 2026-05-18Open, ClassifiedProcess control
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
- 2026-01-16Open, ClassifiedProcess control
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
- 2026-01-16Open, ClassifiedSoftware design
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- 2026-01-16Open, ClassifiedSoftware design
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
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