The Recall Desk

Manufacturer

ICU Medical, Inc.

657 recalls in our database name ICU Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
657
Critical
2
Severe
51
Most recent
2026-07-29

Of the 657 recalls from ICU Medical, Inc. we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 51 (8%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

276–300 of 657

  • HighFDA (Devices)·Z-0133-2020·2019-10-23

    ICU Medical Recalls Sapphire Infusion Sets Due to Potential Fluid Leakage

    ICU Medical Inc is recalling Sapphire Microbore Infusion Sets because fluid may leak from the inline filter air vents.

    Product
    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0128-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

    ICU Medical is recalling specific Plum Microbore Infusion Sets because fluid may leak from the inline filter air vents.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0145-2020·2019-10-23

    ICU Medical Recalls Plum Microbore Infusion Sets Due to Leakage Risk

    ICU Medical Inc is recalling 7,920 units of Plum Microbore Infusion Sets because fluid may leak from the inline filters.

    Product
    Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1094-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap used during assembly.

    Product
    icumedical Oncology Kit w/12" Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3943. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and Delivery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Burr Risk

    ICU Medical is recalling certain lots of ChemoClave Vented Vial Spikes because plastic burrs from the protective cap may contaminate the device.

    Product
    icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contamina
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1095-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate Risk

    ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap.

    Product
    icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets. The ChemoCLAVE Cytotoxic Medication Preparation and De
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1093-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoClave Vented Vial Spikes because they may contain plastic burr particulate from the protective cap.

    Product
    icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminan
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1098-2019·2019-04-24

    ICU Medical Recalls ChemoClave Vial Spikes Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoClave Vial Spikes because they may contain plastic burr particulate from the protective cap.

    Product
    SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1097-2019·2019-04-24

    ICU Medical Recalls ChemoLock Vial Spikes Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoLock Vial Spikes because they may contain plastic burr particulate from the protective cap.

    Product
    icumedical ChemoLock Closed Vial Spike w/Skirt, (a) REF CL-80S-4 (4 units) (b) REF CL-80S-5 (5 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1096-2019·2019-04-24

    ICU Medical Recalls ChemoLock Devices Due to Plastic Particulate

    ICU Medical is recalling specific lots of ChemoLock devices because they may contain plastic burr particulate from the protective cap.

    Product
    icumedical ChemoLock, 20mm, (a) REF CL-80S (b) REF CL-80S-10 (10 units). Used in IV administration sets. The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1070-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation Risk

    ICU Medical is recalling specific lots of Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml Squeeze Flush Device, Macrodrip (Pole Mount), REF: 01C-42640-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1072-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation

    ICU Medical is recalling Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo Flush, Macrodrip (Pole Mount), REF: 42641-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1071-2019·2019-04-03

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Tubing Separation

    ICU Medical is recalling 280 Transpac IV Monitoring Kits because pressure tubing may separate, potentially causing blood loss or air embolism.

    Product
    ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip (Pole Mount), REF: 42640-06, Sterile EO
    Category
    Medical Device
    Distribution
    7 states
  • CriticalFDA (Devices)·Z-0805-2019·2019-03-06

    ICU Medical Recalls ChemoLock Vial Spike Due to Potential Burr Particulate

    ICU Medical is recalling one lot of ChemoLock Vial Spike devices due to a potential for containing burr particulate. The recall covers 2,050 units distributed in the US and internationally.

    Product
    icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the sy
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0509-2019·2019-02-27

    ICU Medical Recalls 0.9% Sodium Chloride Injection Due to CGMP Deviations

    ICU Medical Inc. is voluntarily recalling 475,320 bags of 0.9% Sodium Chloride Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0663-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0662-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling 1,760 units of Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0661-2019·2019-01-02

    ICU Medical Recalls Thermoset Room Temperature Injectate Delivery Systems

    ICU Medical is recalling 27,250 Thermoset Room Temperature Closed Loop Injectate Delivery Systems due to a defect in the thermoset check valve component that may cause leakage.

    Product
    Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0619-2019·2018-12-26

    ICU Medical Recalls Sapphire Epidural Sets Due to Occlusion Alarms

    ICU Medical is recalling 31,050 units of Sapphire Epidural Sets due to reports of distal occlusion alarms during use.

    Product
    SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0215-2019·2018-11-14

    ICU Medical Recalls 5% Dextrose Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 5% Dextrose Injection bags because they may lack sterility and have the potential to leak.

    Product
    5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0216-2019·2018-11-14

    ICU Medical Recalls 0.9% Sodium Chloride Injection Bags Due to Sterility Concerns

    ICU Medical is recalling 2,580,448 bags of 0.9% Sodium Chloride Injection because they may leak and lack assurance of sterility.

    Product
    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 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0069-2019·2018-10-10

    ICU Medical Bifuse Transfer Set Recalled Due to Missing Blood Filter

    ICU Medical is recalling 2,361 Bifuse Transfer Sets because a design change removed the blood filter, creating a risk of use as a blood transfusion set.

    Product
    ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system t
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2655-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    107" (272 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2617-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2648-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

ICU Medical

California-based company that develops, manufactures, and sells medical technologies used in vascular therapy, oncology, and critical care applications

Country
United States
Founded
1984

Official website

Source: Wikidata (Q5969799), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.