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 20, 2020Medical DevicesFDA
ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,
Hazard: Inability for the guidewire to pass through the needles included with the catheter kits.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 584
Hazard: Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotatin
Hazard: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)0
Hazard: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/
Hazard: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI:
Hazard: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp
Hazard: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer,
Hazard: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1 Ext, Rotating Luer, Sterile R, U
Hazard: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Steri
Hazard: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
Hazard: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
May 13, 2020Medical DevicesFDA
ICU Medical, Inc. recalls REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 0514
Hazard: There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
May 6, 2020Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Cogent Hemodynamic Monitoring System, Cogent Item Number 58400-000, UDI: (01)00840619079499
Hazard: Firm identified several software issues through internal testing of its Cogent Hemodynamic Monitoring System. These issues may result in inaccurate monitoring data, unit shutdown, and/or loss of display of a secondary parameter.
November 13, 2019DrugsFDA
ICU Medical Inc recalls 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983
Hazard: Presence of Particulate Matter.
November 13, 2019DrugsFDA
ICU Medical Inc recalls LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-795
Hazard: Presence of Particulate Matter.
October 30, 2019Medical DevicesFDA
ICU Medical Inc recalls Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump.
Hazard: A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidura
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUM
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
October 23, 2019Medical DevicesFDA
ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.