ICU Medical Recalls
657 recalls on record · August 8, 2012 to July 29, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 29, 2026Medical DevicesFDA
ICU Medical Inc. recalls Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the p
Hazard: 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.
July 22, 2026Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
Hazard: 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.
July 22, 2026Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Hazard: 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.
June 17, 2026Medical DevicesFDA
ICU Medical, Inc. recalls Plum Duo Precision IV Pump, 40002-0403
Hazard: 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.
June 17, 2026Medical DevicesFDA
ICU Medical, Inc. recalls Plum Duo Infusion Pump, 40002-0401
Hazard: 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.
June 17, 2026Medical DevicesFDA
ICU Medical, Inc. recalls Plum Solo Precision IV Pump, 40001-0401
Hazard: 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.
May 27, 2026Medical DevicesFDA
ICU Medical, Inc. recalls Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock
Hazard: 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.
January 28, 2026Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Hazard: 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.
January 28, 2026Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Hazard: 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.
January 28, 2026Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Hazard: 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.
January 28, 2026Medical DevicesFDA
ICU Medical, Inc. recalls Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Hazard: 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
January 21, 2026Medical DevicesFDA
ICU Medical Inc. recalls Portex Spinal Tray, Item No. A3729-24 A3595
Hazard: Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
January 21, 2026Medical DevicesFDA
ICU Medical Inc. recalls Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Hazard: Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
January 21, 2026Medical DevicesFDA
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number 40002-04-01
Hazard: ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
December 31, 2025Medical DevicesFDA
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Hazard: Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
December 31, 2025Medical DevicesFDA
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Hazard: For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/Chem
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.