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.
98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Admi...
Medical Devices·50 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: ...
Medical Devices·600 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Bl...
Medical Devices·900 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (Whit...
Medical Devices·1,500 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 ...
Medical Devices·5,100 affected·Apr 20, 2015
High RiskFDA
Icu Medical, Inc.
108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326
Medical Devices·13,800 affected·Apr 20, 2015
CriticalFDA
Icu Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9...
Medical Devices·1,250 affected·Aug 19, 2014
CriticalFDA
Icu Medical, Inc.
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usag...
Medical Devices·100 affected·Aug 19, 2014
CriticalFDA
Icu Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9...
Medical Devices·3,750 affected·Aug 19, 2014
High RiskFDA
Icu Medical, Inc.
Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and ...
Medical Devices·300 affected·Aug 5, 2014
High RiskFDA
Icu Medical, Inc.
Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and...
Medical Devices·400 affected·Aug 5, 2014
High RiskFDA
Icu Medical, Inc.
Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Tran...
Medical Devices·20 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcat...
Medical Devices·40 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifur...
Medical Devices·640 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated moni...
Medical Devices·900 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monito...
Medical Devices·200 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Tri...
Medical Devices·1,560 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safe...
Medical Devices·100 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated mon...
Medical Devices·50 affected·Jul 18, 2014
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. The ICU Needleless Connector is...
Medical Devices·800 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a sin...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item ...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029 The ICU ...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, ...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 ...
Medical Devices·100 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave...
Medical Devices·250 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 The ICU Needl...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device inten...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TCo...
Medical Devices·250 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, It...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿ Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 27...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096,...
Medical Devices·100 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Nee...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU N...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave¿, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, 3 Ex...
Medical Devices·1,300 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, st...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Need...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connec...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 The ICU Needleles...
Medical Devices·50 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Need...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 T...
Medical Devices·4,000 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needle...
Medical Devices·700 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needl...
Medical Devices·500 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item N...
Medical Devices·10,400 affected·Dec 24, 2013
High RiskFDA
Icu Medical, Inc.
8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is ...
Medical Devices·50 affected·Dec 24, 2013