The Recall Desk

Manufacturer

ICU Medical, Inc.

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

What the numbers show

Total
666
Critical
2
Severe
60
Most recent
2026-09-23

Of the 666 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 60 (9%) 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.

101–125 of 666

  • HighFDA (Devices)·Z-1584-2021·2021-05-19

    ICU Medical Recalls Sprios IV Adapters Due to Leakage Defect

    ICU Medical is recalling specific lots of Sprios IV adapters because a molding defect may cause leakage in the inactivated position.

    Product
    REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2021·2021-05-19

    ICU Medical Recalls Spiros Male Luer Extensions Due to Leakage

    ICU Medical is recalling Spiros male luer extensions due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2021·2021-05-19

    ICU Medical Recalls Spiros Transfer Sets Due to Molding Defect

    ICU Medical is recalling Spiros transfer sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2021·2021-05-19

    ICU Medical Recalls Sprios Male Luer Administration Sets Due to Leakage

    ICU Medical is recalling specific lots of Sprios male luer administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1570-2021·2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1585-2021·2021-05-19

    ICU Medical Recalls Spiros Closed Male Luer Due to Leakage Defect

    ICU Medical is recalling Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1571-2021·2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-In Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1576-2021·2021-05-19

    ICU Medical Recalls 20mL Syringes Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of 20mL syringes with Spinning Spiros due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1569-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Closed Male Luer Due to Leakage

    ICU Medical is recalling certain lots of Spinning Spiros Closed Male Luer devices due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1577-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Syringes Due to Leakage Defect

    ICU Medical is recalling specific lots of 60mL Spinning Spiros syringes because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1567-2021·2021-05-19

    ICU Medical Recalls Spiros Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1581-2021·2021-05-19

    ICU Medical Recalls Admin Sets Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of REF 011-CH3967 Admin Sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1588-2021·2021-05-19

    ICU Medical Recalls Spiros Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Spiros administration sets because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1580-2021·2021-05-19

    ICU Medical Recalls Smallbore Trifuse Extension Sets Due to Leakage Defect

    ICU Medical is recalling specific lots of Smallbore Trifuse Extension Sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1578-2021·2021-05-19

    ICU Medical Recalls Sprios Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of Sprios administration sets due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1572-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect

    ICU Medical is recalling specific lots of REF CL3538 Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1565-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Molding Defect and Leakage

    ICU Medical is recalling specific lots of Oncology Kits due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1586-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Molding Defect

    ICU Medical is recalling specific lots of Spinning Spiros male luers because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1590-2021·2021-05-19

    ICU Medical Recalls Spinning Spiros Male Luers Due to Leakage Defect

    ICU Medical is recalling specific lots of Spinning Spiros Closed Male Luers because a molding defect may cause leakage in the inactivated position.

    Product
    REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1587-2021·2021-05-19

    ICU Medical Recalls Bag Spike Adapters Due to Molding Defect

    ICU Medical is recalling specific lots of Bag Spike Adapters due to a molding defect that may cause leakage in the inactivated position.

    Product
    REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1575-2021·2021-05-19

    ICU Medical Recalls Smallbore Extension Sets Due to Molding Defect

    ICU Medical is recalling specific lots of smallbore extension sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1589-2021·2021-05-19

    ICU Medical Recalls IV Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of IV administration sets because a molding defect may cause leakage in the inactivated position.

    Product
    REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag Hanger - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1574-2021·2021-05-19

    ICU Medical Recalls Oncology Kits Due to Potential Leakage Defect

    ICU Medical is recalling specific lots of Oncology Kits because a molding defect may cause small amounts of leakage in the inactivated position.

    Product
    REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock; Syringe Transfer Set w/MicroClave, w/ChemoLock Port - Product Usage: provides access for the administration of fluids from a container to a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0958-2021·2021-02-17

    ICU Medical Recalls Intravascular Administration Sets Due to Filter Assembly Error

    ICU Medical is recalling 7,500 intravascular administration sets because of an incorrect filter assembly. The affected devices are distributed worldwide and across multiple U.S. states.

    Product
    154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: 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 through the…
    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.