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.

101–125 of 657

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-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 c
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-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-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-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-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 needl
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-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-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-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 pa
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-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-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 needle
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0313-2021·2021-03-31
ICU Medical Recalls Sodium Chloride Irrigation Due to Particulate Matter
ICU Medical is recalling 425,628 bottles of 0.9% Sodium Chloride Irrigation due to the presence of particulate matter.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0955-2021·2021-02-17
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 were distributed in the U.S. and Belgium.
Product
60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - 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 throu
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 ad
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0957-2021·2021-02-17
ICU Medical Recalls MicroCLAVE Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 MicroCLAVE intravascular administration sets due to incorrect filter assembly. The affected lots were distributed nationwide in the U.S. and in Belgium.
Product
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - 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 throug
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0956-2021·2021-02-17
ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Filter Assembly Error
ICU Medical is recalling 7,500 smallbore intravascular administration sets because of an incorrect filter assembly. The affected lots were distributed nationwide and in Belgium.
Product
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - Product Usage: The intravascular administration set is a single use, sterile, non pyrogenic device, which provides access for the administration of fluids from a
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0859-2021·2021-01-20
ICU Medical Cogent Hemodynamic Monitoring System Recalled for Software Issue
ICU Medical is recalling 220 Cogent Hemodynamic Monitoring Systems because a software issue may cause the display to show incorrect continuous cardiac output values after calibration.
Product
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0707-2021·2020-12-30
ICU Medical Recalls ChemoLock Administration Sets Due to Molding Defect
ICU Medical is recalling specific ChemoLock administration sets because a molding defect may cause leaks. This could lead to fluid path contamination or exposure to hazardous medications.
Product
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3020; ChemoLock Port w/Spiros, Red Cap, REF: CL-35; 3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0708-2021·2020-12-30
ICU Medical Recalls Oncology and Administration Sets Due to Molding Defect
ICU Medical is recalling specific oncology and administration sets because a molding defect in male luers may cause leaks, potentially leading to fluid path contamination or exposure to hazardous medications.
Product
76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF: 011-CH3261; 44 cm(17 IN) Appx 2.9 ml,PUR YELLOW TRANS SET,ChemoClave,CK VLV,Spiros,PURPLE CAP, REF: 011-CH3568; Oncology Kit, 5 Gang Stopcock w/5 ChemoClave,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0701-2021·2020-12-30
ICU Medical Recalls Spiros and Clave IV Administration Sets
ICU Medical is recalling specific Spiros and Clave IV administration sets due to a molding defect that may cause leaks in spinning male luer components.
Product
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integrated Clave Drip Chamber, Clave, Spiros, REF: CH3035; 40" (102 cm) Appx 4.5 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Hanger, REF: CH3135;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0700-2021·2020-12-30
ICU Medical Recalls Spinning Spiros and ChemoAccess Infusion Components
ICU Medical is recalling specific infusion components due to a molding defect that may cause leaks, risking fluid contamination or exposure to hazardous medications.
Product
Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, Clave,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0710-2021·2020-12-30
ICU Medical Recalls Appx 1.7 ml Bag Spike Due to Molding Defect
ICU Medical is recalling 900 units of Appx 1.7 ml Bag Spike w/Integrated Clave due to a molding defect that may cause leaks in male luers.
Product
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
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.