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.

576–600 of 657

HighFDA (Devices)·Z-1256-2016·2016-04-06
ICU Medical Recalls IV Infusion Sets with Potential ChemoLock Port Leak
ICU Medical is recalling specific IV infusion administration sets because the connection between the drip chamber or bag spike and the ChemoLock port may develop a leak.
Product
30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal of fluids.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1257-2016·2016-04-06
ICU Medical Recalls I.V. Infusion Sets with Potential Leak
ICU Medical is recalling specific I.V. infusion administration sets because a connection may develop a leak. The recall affects 350 units distributed in the US and internationally.
Product
110" (279 cm) Appx 13.8 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Clave, Rotating Luer, Bag Hanger, Item No. AHCL3300 sterile devices intended for the infusion and withdrawal of fluids.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1260-2016·2016-04-06
ICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk
ICU Medical is recalling specific IV administration sets with ChemoLock ports because the connection may develop a leak.
Product
30" (76 cm) Appx. 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. CL3528 sterile devices intended for the infusion and withdrawal of fluids.
Category
Medical Device
Distribution
14 states
HighFDA (Devices)·Z-1589-2015·2015-05-13
ICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage
ICU Medical is recalling MicroClave T-Connectors because potential connection separation issues could lead to leakage.
Product
107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1594-2015·2015-05-13
ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk
ICU Medical is recalling MicroClave T-Connectors because potential connection separation issues could lead to leakage.
Product
98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1593-2015·2015-05-13
ICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage
ICU Medical is recalling 5,100 units of MicroClave T-Connectors because potential connection separation issues could lead to leakage.
Product
127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1590-2015·2015-05-13
ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation
ICU Medical is recalling 1,500 MicroClave T-Connectors because potential connection separation issues could lead to leakage.
Product
104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 Product Usage: IV Administration sets are intended for the infusion and with
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1591-2015·2015-05-13
ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk
ICU Medical is recalling specific MicroClave T-Connectors because they may separate, causing fluid leakage.
Product
113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage: IV Administration sets are intended for the infusion and wi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1592-2015·2015-05-13
ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk
ICU Medical is recalling 13,800 MicroClave T-Connectors because potential connection separation issues could lead to leakage.
Product
108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1588-2015·2015-05-13
ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk
ICU Medical is recalling specific MicroClave T-Connectors because they may separate, causing fluid leakage. The recall affects 250 units distributed in nine US states.
Product
119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and withdra
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1595-2015·2015-05-13
ICU Medical Recalls 98-inch Transfer Sets Due to Connection Separation
ICU Medical is recalling 50 units of 98-inch Transfer Sets because potential connection separation could lead to leakage.
Product
98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2622-2014·2014-10-01
ICU Medical Recalls Stat 2 Flow Controllers Due to Flow Rate Issues
ICU Medical is recalling specific IV administration sets because the Stat 2 flow controller may deliver a significantly higher flow rate than intended.
Product
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2621-2014·2014-10-01
ICU Medical Recalls Stat 2 Flow Controllers Due to High Flow Rate Risk
ICU Medical is recalling 100 units of ConMed Stat 2 flow controllers because they may deliver a significantly higher flow rate than intended.
Product
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 Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2619-2014·2014-10-01
ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate
ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.
Product
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-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2620-2014·2014-10-01
ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate Risk
ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.
Product
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-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2014·2014-08-27
ICU Medical Recalls Port Access Kits with Potential Sterility Issues
ICU Medical is recalling Port Access Kits with MicroClave Clear Connectors because some packages may have open seals, potentially compromising sterility.
Product
Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2294-2014·2014-08-27
ICU Medical Recalls BD PosiFlush Syringes Due to Open Seals
ICU Medical is recalling BD PosiFlush Sterile Field Saline Flush Syringes because some packages may have open seals, potentially compromising sterility.
Product
Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2293-2014·2014-08-27
ICU Medical Recalls CAP Change Kits Due to Potential Sterility Issues
ICU Medical is recalling CAP Change Kits with MicroClave Clear because some packages may have open seals, potentially compromising sterility.
Product
CAP Change Kit w/MicroClave Clear, Item No. B78109 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2159-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.
Product
Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2158-2014·2014-08-13
ICU Medical Recalls Trifurcated Transpac IT Monitoring Kits Due to Leak Risk
ICU Medical is recalling 40 units of Trifurcated Transpac IT Monitoring Kits because a component connection may crack and cause a fluid leak.
Product
Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2164-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.
Product
Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fl
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2163-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Potential Fluid Leak
ICU Medical is recalling 100 units of Transpac IT arterial monitoring kits because a component connection may crack and cause a fluid leak.
Product
Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion,
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2160-2014·2014-08-13
ICU Medical Recalls Trifurcated Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 60 units of Trifurcated Transpac IV Monitoring Kits because a component connection may crack and cause a fluid leak.
Product
Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montori
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2162-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling specific arterial monitoring kits because a component connection may crack, causing a fluid leak.
Product
Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressu
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2161-2014·2014-08-13
ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling 200 arterial monitoring kits because a component connection may crack, causing a fluid leak.
Product
Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure
Category
Medical Device
Distribution
1 state

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.