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.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides acces
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the admini
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Ca
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a contai
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the adm
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides a
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provid
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a co
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides a
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hang
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids fro
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids fro
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/Chem
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spir
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Re
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Re
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger -
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluid
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 514297
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the pre
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
March 31, 2021DrugsFDA
ICU Medical Inc recalls 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest
Hazard: Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
February 17, 2021Medical DevicesFDA
ICU Medical, Inc. recalls 154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a
Hazard: Due to the incorrect filter assembly.
February 17, 2021Medical DevicesFDA
ICU Medical, Inc. recalls 7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration s
Hazard: Due to the incorrect filter assembly.
February 17, 2021Medical DevicesFDA
ICU Medical, Inc. recalls 60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - P
Hazard: Due to the incorrect filter assembly.
February 17, 2021Medical DevicesFDA
ICU Medical, Inc. recalls 60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration
Hazard: Due to the incorrect filter assembly.
January 20, 2021Medical DevicesFDA
ICU Medical, Inc. recalls icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of conti
Hazard: Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.