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
High RiskFDA
Icu Medical, Inc.
Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090
Medical Devices·27,250 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090
Medical Devices·1,760 affected·Oct 5, 2018
High RiskFDA
Icu Medical, Inc.
ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a sin...
Surgical Devices·2,361 affected·Aug 20, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02
Injectable Drugs·941,496 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02
Injectable Drugs·267,288 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37
Injectable Drugs·1,247,200 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23
Injectable Drugs·525,984 affected·May 31, 2018
High RiskFDA
Icu Medical Inc
0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37
Injectable Drugs·88,960 affected·May 31, 2018
High RiskFDA
Icu Medical, Inc.
6.5" (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk Non-Sterile, 500 per case, It...
Surgical Devices·11,500 affected·Feb 5, 2018
High RiskFDA
Icu Medical, Inc.
14 cm (5.5") Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item IR-NG31481B, St...
Surgical Devices·7,600 affected·Feb 5, 2018
High RiskFDA
Icu Medical, Inc.
5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The...
Surgical Devices·100 affected·Feb 5, 2018
High RiskFDA
Icu Medical Inc
ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet ...
Medical Devices·108 affected·Oct 30, 2017
High RiskFDA
Icu Medical, Inc.
SURPLUG MICRO CONNECTOR Item No. 066-C3352; 111" (282 cm) Appx 13.9 ml, 15 Drop Admin Set w/3-Way Stopcock, 1 Ext, Luer Slip Item No. B...
Surgical Devices·24,475 affected·Aug 31, 2017
High RiskFDA
Icu Medical, Inc.
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tu...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing acc...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
120" (305 cm) 10 Drop Primary Set w/2 MicroClave¿, Hand Pump, Remv 2 Gang 4-Way Stopcock, Y-Connector, Rotating Luer, 1 Ext, Sterile T...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
Lopez Valve¿ w/Red Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intende...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
132" (335 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, 2 Clave¿, Remv 2 Gang 4-Way Stopcocks, Luer Lock, 2 Ext, Sterile The blo...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
99" (251 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
98" (249 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Gang 4-Way Stopcocks, Clave¿, Rotating Luer, 1 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE C...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, St...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
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 ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
115" (292 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Prepierced Ports¿, T-Connector w/Pre-Pierced Port, Luer Slip, 2 Ext, Ste...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
112" (284 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, Sterile The blood tubing accessory wit...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
116" (295 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 MicroClave¿, 2 Ext, Rotating Luer, Sterile The blood tubing accessory...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Con...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
162" Y-Type Blood Set w/170 Micron Filter, Bulb Hand Pump, 3 Pre-Pierced Ports, 4 Gang 4-Way Stopcocks w/Baseplate, 3 Remv Ext, Rotating ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood t...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Vol...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
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 Th...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
218 cm (86") Appx 16.4 ml, 20 Drop Blood Set w/200 Micron Filter, 2 MicroClave¿, Check Valve, Y-Connector, Rotating Luer, Sterile The ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
139" (353 cm) Y-Type Blood Set w/ 170 Micron Filter, Hand Pump, BCV, 3-Gang w/2 4-Way Stopcocks w/Baseplate, 1o2¿ Valve, 2 Clave¿, Pre-Pi...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Conn...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, MicroClave¿ Clear, Rotating Luer, Approx Priming Volume: 57.2 mL, Sterile ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
94" (239 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector i...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
132" (335 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, 4-Way Stopcock, Rotating Luer, 1 Ext, Sterile The blood tubing ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
134" (340 cm) Y-Type Admin Set w/170 Micron Blood Filter, Pump, Clave¿, 2 Gang 4-Way Stopcocks, Rotating Luer w/Filter Cap, 2 Ext, Steril...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer,...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rota...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile Th...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The b...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017