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.
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 High-Pressur
Hazard: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
April 24, 2019Medical DevicesFDA
ICU Medical, Inc. recalls SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-
Hazard: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
April 24, 2019Medical DevicesFDA
ICU Medical, Inc. recalls icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV
Hazard: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
April 24, 2019Medical DevicesFDA
ICU Medical, Inc. recalls icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The Ch
Hazard: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
April 24, 2019Medical DevicesFDA
ICU Medical, Inc. recalls icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike,
Hazard: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
April 24, 2019Medical DevicesFDA
ICU Medical, Inc. recalls icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm;
Hazard: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
April 24, 2019Medical DevicesFDA
ICU Medical, Inc. recalls icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a need
Hazard: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
April 24, 2019Medical DevicesFDA
ICU Medical, Inc. recalls icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a nee
Hazard: There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.
April 3, 2019Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transduce
Hazard: Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
April 3, 2019Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transduce
Hazard: Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
April 3, 2019Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable
Hazard: Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.
March 6, 2019Medical DevicesFDA
ICU Medical, Inc. recalls icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the tran
Hazard: There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate
February 27, 2019DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC
Hazard: CGMP Deviations
January 2, 2019Medical DevicesFDA
ICU Medical, Inc. recalls Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per c
Hazard: Potential for leakage due to defect in the thermoset check valve component.
January 2, 2019Medical DevicesFDA
ICU Medical, Inc. recalls Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per
Hazard: Potential for leakage due to defect in the thermoset check valve component.
January 2, 2019Medical DevicesFDA
ICU Medical, Inc. recalls Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R
Hazard: Potential for leakage due to defect in the thermoset check valve component.
December 26, 2018Medical DevicesFDA
ICU Medical Inc recalls SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidu
Hazard: There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
November 14, 2018DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-79
Hazard: Lack of Assurance of Sterility; bags have the potential to leak
November 14, 2018DrugsFDA
ICU Medical Inc recalls 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, I
Hazard: Lack of Assurance of Sterility; bags have the potential to leak
October 10, 2018Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administra
Hazard: Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, Sterile The blood
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
August 15, 2018Medical DevicesFDA
ICU Medical, Inc. recalls 117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 E
Hazard: Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.