Brand

Icu Medical Inc Recalls

441 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Icu Medical Inc.

441Total Recalls
20Critical
66.1MUnits Affected
Dec 19, 2025Most Recent
All Recalls

Every Icu Medical Inc Recall

Sorted by most recent. Click any recall for full details.

441 recalls
CriticalFDA
Icu Medical Inc
ASM Replacement Battery, Component Number SUB0000864
Medical Devices·9,984 affected·Mar 22, 2023
CriticalFDA
Icu Medical Inc
ASM Replacement Battery, Component Number SUB0000594
Medical Devices·344 affected·Mar 22, 2023
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 09...
Injectable Drugs·137,120 affected·Nov 9, 2022
High RiskFDA
Icu Medical, Inc.
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administratio...
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL....
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or art...
Surgical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
Medical Devices·5,795,989 affected·Aug 1, 2022
High RiskFDA
Icu Medical, Inc.
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,Che...
Medical Devices·454,635 affected·Jun 27, 2022
High RiskFDA
Icu Medical, Inc.
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20...
Medical Devices·358,975 affected·Jun 27, 2022
CriticalFDA
Icu Medical Inc
AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC...
Injectable Drugs·2,112 affected·Sep 3, 2021
High RiskFDA
Icu Medical, Inc.
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product U...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to ...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
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 Usag...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
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;...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and p...
Medical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
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 pati...
Medical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
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...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
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, Dro...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient ...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
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...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the adm...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
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 adm...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
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 ...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Cap - Product Usage...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product U...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical Inc
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045...
Drugs·425,628 affected·Mar 9, 2021
High RiskFDA
Icu Medical, Inc.
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...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a single use, steri...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration set is a single us...
Surgical Devices·7,500 affected·Dec 2, 2020
High RiskFDA
Icu Medical, Inc.
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac out...
Cardiac Devices·220 affected·Nov 9, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3...
Medical Devices·231,250 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795
Medical Devices·2,900 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave Drip Chamber, Spir...
Medical Devices·19,850 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrated ChemoClave Dri...
Medical Devices·217,522 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: CH3286
Medical Devices·325 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
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 ...
Medical Devices·55,000 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260
Medical Devices·900 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
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 ...
Medical Devices·4,790 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Mal...
Medical Devices·1,856,578 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034; 5" (13 cm) Appx...
Medical Devices·37,000 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
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....
Medical Devices·88,700 affected·Aug 31, 2020
High RiskFDA
Icu Medical, Inc.
APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 Ext; 1 unit per p...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve, Rotating Luer, 1...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)1088770...
Surgical Devices·1 affected·Jul 6, 2020