Manufacturer

ICU Medical, Inc.

64 recalls in our database name ICU Medical, Inc. as the manufacturing or recalling firm.

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.

26–50 of 64

HighFDA (Devices)·Z-0339-2026·2025-11-05
ICU Medical Extension Set Port Weld May Separate During Use
ICU Medical's 60-inch extension set with ChemoLock port may have a defective weld that could separate or break during use, potentially causing a leak. The recall affects 200 units distributed nationwide and internationally.
Product
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0345-2026·2025-11-05
ICU Medical ChemoLock Vial Spike weld may separate during use
ICU Medical is recalling ChemoLock Vented Vial Spike units due to a weld defect that may separate or break, potentially causing leaks during drug transfer. Approximately 9,004 units distributed worldwide are affected.
Product
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0348-2026·2025-11-05
ICU Medical ChemoLock Closed Vial Spike Weld May Separate During Use
A weld defect in the ICU Medical ChemoLock Closed Vial Spike may cause the device to separate or leak during use in healthcare drug transfer applications. The recall affects 8,475 units distributed in the US and internationally.
Product
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0351-2026·2025-11-05
ICU Medical extension set with ChemoLock port weld defect recalled
ICU Medical is recalling 950 units of a 21-inch extension set with ChemoLock port due to a weld defect that may cause leakage during use. Affected units were distributed nationwide and internationally.
Product
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0337-2026·2025-11-05
ICU Medical Drug Transfer Kit Port Weld May Separate During Use
ICU Medical is recalling 600 units of its Oncology Transfer Kit due to a potential weld failure in the port that could cause leaks during use. The device transfers hazardous drugs in oncology settings.
Product
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0333-2026·2025-11-05
ICU Medical IV Drug Administration Set Recalled for Port Weld Failure
ICU Medical is recalling 7,950 units of its ChemoLock-equipped IV drug administration sets due to potential port weld separation that could cause leakage during use.
Product
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Bag Hanger REF: CL3511
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0350-2026·2025-11-05
ICU Medical ChemoLock Port weld may separate during use
ICU Medical is recalling ChemoLock Ports due to a weld defect that may separate or break during use, potentially causing drug leaks.
Product
ICU Medical ChemoLock Port REF: CL2100
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0336-2026·2025-11-05
ICU Medical Oncology Kit port weld may separate during use
ICU Medical is recalling its Oncology Kit with ChemoLock (REF: CL4136) due to a potential defect in the port weld of the drug transfer device. The weld may separate or break during use, potentially causing a leak.
Product
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0361-2026·2025-11-05
ICU Medical Extension Set Port Weld May Separate or Leak
ICU Medical extension sets may develop weld separation in the port, potentially causing leaks during use. FDA Class II recall affects 1,600 units distributed nationwide and internationally.
Product
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0343-2026·2025-11-05
ICU Medical ChemoLock Vial Spike: Potential Weld Failure and Leak Risk
ICU Medical is recalling ChemoLock Universal Vented Vial Spikes due to potential weld failure in the port that could cause leakage during use. The defect affects approximately 16,850 units distributed nationwide and internationally.
Product
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0357-2026·2025-11-05
ICU Medical ChemoLock Port Weld May Separate During Use
ICU Medical is recalling ChemoLock Port devices because the port weld may separate or break during use, potentially causing drug leaks. No injuries have been reported.
Product
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0330-2026·2025-11-05
ICU Medical ChemoLock Port Weld May Separate During Use
ICU Medical recalled ChemoLock ports where the weld may separate during use, potentially causing drug leakage. 2,000 units are affected.
Product
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0364-2026·2025-11-05
Port Weld Defect in ICU Medical ChemosafeLock Drug Transfer Device
The port weld in ICU Medical ChemosafeLock connecters (REF: KL-FNU3) may separate or break during use, potentially causing drug leakage. Approximately 134,700 units have been distributed worldwide.
Product
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0356-2026·2025-11-05
Syringe Transfer Set Recalled for Potential Port Weld Separation Risk
ICU Medical is recalling 900 units of its Syringe Transfer Set with ChemoLock Port due to a potential port weld defect that may separate or break during use, risking drug leakage.
Product
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0354-2026·2025-11-05
ICU Medical ChemoLock Vented Vial Spike weld may separate or break
ICU Medical is recalling ChemoLock Vented Vial Spikes (Lot 14401659) because the port weld may separate or break during use, potentially resulting in leaks.
Product
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0329-2026·2025-11-05
ICU Medical Vial Spike Weld Failure May Cause Drug Leak
ICU Medical is recalling 2,100 Chemo Lock Universal Vented Vial Spikes (Lot 14380109) due to port weld defects that may separate or break during use, potentially leaking drug contents.
Product
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0353-2026·2025-11-05
ICU Medical bag spike port weld may separate or break
A weld on ICU Medical bag spike components may separate during use, potentially causing drug leakage.
Product
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0332-2026·2025-11-05
ICU Medical Admin Set Port Weld May Separate, Causing Leaks
ICU Medical is recalling 11,000 units of its 30-inch Admin Set due to a defect in the port weld that may separate or break during use, potentially causing the device to leak.
Product
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Red Cap REF: CL3011
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0365-2026·2025-11-05
ChemosafeLock Vial Adapter port weld may separate and cause drug leakage
ICU Medical is recalling ChemosafeLock Vial Adapters due to a port weld defect that may separate or break during use, potentially causing drug leakage. Approximately 202,900 units are affected worldwide.
Product
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0347-2026·2025-11-05
ChemoLock Vial Spike Weld Defect May Cause Drug Leakage During Use
ICU Medical is recalling 53,050 ChemoLock Vial Spikes due to weld defects that may cause drug leakage during use. Affected units are distributed in the US, Canada, France, and Japan.
Product
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0352-2026·2025-11-05
ICU Medical Drug Transfer Connector May Leak Due to Weld Defect
ICU Medical is recalling approximately 1,700 units of its Graduated Connector w/ChemoLock Port because the device's port weld may separate or break during use, potentially causing leaks.
Product
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0154-2026·2025-10-29
IV Burette Administration Sets Recalled for Missing Internal Shutoff Valve
ICU Medical recalls over 23,000 IV burette administration sets with a missing internal shutoff valve that could result in uncontrolled fluid flow or air infusion during patient care.
Product
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 150 ml Burette Set (w/Shut Off), MicroClave, Clamp, REF: B9213; 70" (178 cm) 150 ml Burette Set (Clave, Shut-Off) w/3-Way Stopcock, Clave, Graduated Adapter,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2129-2025·2025-08-13
Plum Duo Infusion System User Interface May Become Unresponsive
Approximately 4,677 Plum Duo Infusion Systems may experience user interface unresponsiveness due to programming events and alarm interactions. Users should contact ICU Medical for guidance on affected units.
Product
Plum Duo Infusion System, List Number: 400020401
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2116-2025·2025-07-23
SwabCap Disinfecting Cap Needlefree Connector Seal Defect Recall
ICU Medical is recalling SwabCap Disinfecting Caps due to a manufacturing defect that may prevent proper disinfection of needlefree connectors. The incomplete seal may cause isopropyl alcohol to evaporate, reducing effectiveness.
Product
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1991-2025·2025-06-25
ICU Medical Plum Solos infusion pump may bypass maximum dose limit alert
ICU Medical Plum Solos infusion pumps with software version 1.1.1 may have a workflow that bypasses the Maximum Dose Limit alert, which prevents overdosing patients on weight or body surface area-based medications.
Product
ICU Medical Plum Solos, Item number 400011001; infusion pump
Category
Medical Device
Distribution
Distributed nationwide