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.
139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer, 2 Ext. 1 unit p...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connector, 3 Purple Clam...
Medical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10887709085814(...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(17)250201(30)50(1...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(17)250101(30)50(10...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)10840619066052(17)25...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouches per case. UDI:...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)24120...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blu...
Surgical Devices·1,100 affected·Jul 1, 2020
CriticalFDA
Icu Medical Inc
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Injectable Drugs·93,648 affected·May 8, 2020
High RiskFDA
Icu Medical, Inc.
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619...
Cardiac Devices·123 affected·Feb 14, 2020
High RiskFDA
Icu Medical, Inc.
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary ar...
Surgical Devices·235 affected·Jan 2, 2020
High RiskFDA
Icu Medical, Inc.
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary ar...
Surgical Devices·20 affected·Jan 2, 2020
CriticalFDA
Icu Medical Inc
0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
Injectable Drugs·58,464 affected·Oct 25, 2019
CriticalFDA
Icu Medical Inc
LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
Injectable Drugs·389,808 affected·Oct 25, 2019
High RiskFDA
Icu Medical, Inc.
REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
Medical Devices·4,800 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00...
Medical Devices·650 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00...
Medical Devices·14,000 affected·Oct 4, 2019
High RiskFDA
Icu Medical, Inc.
REF: Z2850, 112" (284 cm) 10 Drop Primary set w/2 Clave, Remv 3 Gang 1o2 Manifold w/3 Clave, Baseplate, Rotating Luer w/Filter Cap, 1 Ext...
Medical Devices·25 affected·Oct 4, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron F...
Medical Devices·78,877 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micr...
Medical Devices·19,350 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micr...
Medical Devices·45,900 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yel...
Medical Devices·400 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yel...
Medical Devices·155,150 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit ...
Medical Devices·7,920 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set wit...
Medical Devices·120 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yel...
Medical Devices·6,516 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micr...
Medical Devices·32,416 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron F...
Medical Devices·521 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY ...
Medical Devices·170,735 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Fi...
Medical Devices·6,400 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micr...
Medical Devices·5,443 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Strip...
Medical Devices·1,536 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Fil...
Medical Devices·14,850 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set wit...
Medical Devices·4,600 affected·Jul 29, 2019
High RiskFDA
Icu Medical Inc
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micr...
Medical Devices·2,327 affected·Jul 29, 2019
CriticalFDA
Icu Medical, Inc.
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 s...
Medical Devices·23,800 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets. The ChemoClave is a needle-free Closed Syste...
Medical Devices·3,500 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-80S. Used in IV administration sets. The ChemoClave is a needle-free Closed Sy...
Medical Devices·60,500 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
icumedical ChemoClave Vented Vial Spike, 20 mm, REF CH-70S . Used in IV administration sets. The ChemoClave is a needle-free Closed S...
Medical Devices·27,200 affected·Feb 21, 2019
CriticalFDA
Icu Medical, Inc.
icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave...
Medical Devices·300 affected·Feb 21, 2019
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-09
Injectable Drugs·475,320 affected·Feb 4, 2019
High RiskFDA
Icu Medical, Inc.
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 152 cm (60") Tubing, Disposable Transducer, 03 ml...
Medical Devices·5,000 affected·Nov 27, 2018
High RiskFDA
Icu Medical, Inc.
ICU Medical, Transpac IV Monitoring Kit With Safeset Reservoir and Blood Sampling Port, 60" Tubing, Disposable Transducer, 3 ml Intraflo ...
Medical Devices·0 affected·Nov 27, 2018
High RiskFDA
Icu Medical Inc
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indi...
Medical Devices·31,050 affected·Nov 8, 2018
High RiskFDA
Icu Medical Inc
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 ...
Injectable Drugs·2,580,448 affected·Oct 8, 2018
High RiskFDA
Icu Medical Inc
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
Injectable Drugs·372,912 affected·Oct 8, 2018
High RiskFDA
Icu Medical, Inc.
Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
Medical Devices·25,640 affected·Oct 5, 2018