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.

1–25 of 64

HighFDA (Devices)·Z-2210-2026·2026-05-27
Oncology Kit With Extension Sets May Leak During Infusion Therapy
ICU Medical is recalling Oncology Kits with extension sets due to potential leaks that could interrupt chemotherapy infusion and expose hazardous substances to patients, caregivers, and pharmacy technicians.
Product
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1120-2026·2026-01-28
ICU Medical IV pump software malfunction prevents piggyback flush programming
ICU Medical Plum Solo Precision IV pumps may display error messages preventing clinicians from programming the automatic downstream line flush after piggyback therapy.
Product
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1118-2026·2026-01-28
ICU Medical Plum Duo infusion pump software prevents flush feature programming
ICU Medical Plum Duo infusion pumps have a software issue preventing clinicians from programming the automatic flush feature after piggyback therapy, affecting this critical safety function.
Product
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2026·2026-01-28
Tego Needle-Free Connectors Recalled for Silicone Seal Separation Risk
ICU Medical is recalling Tego needle-free connectors used in hemodialysis and IV administration because the silicone seal may separate or tear, potentially causing fluid leaks, therapy delays, or exposure to harmful contaminants.
Product
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1119-2026·2026-01-28
ICU Medical Plum IV Pump software blocks programming of therapeutic flush
ICU Medical Plum Solo and Duo Infusion Pumps may prevent programming of a flush feature after piggyback therapy due to software limit errors. Error messages block this intended pump function.
Product
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1094-2026·2026-01-21
Plum Duo Infusion Pump speaker defects may silence alarms
ICU Medical recalls Plum Duo Infusion Systems with defective speakers that may fail to produce sound. If the speaker fails, patients and caregivers may not hear pump alarms or alerts.
Product
Plum Duo Infusion System, List Number 40002-04-01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0966-2026·2025-12-31
LifeShield Infusion Software Recalled for Concentration Limit Precision Defect
LifeShield Drug Library Management software limits drug concentration precision to one decimal place instead of three, potentially forcing users to deviate from manufacturer recommendations and risking medication delivery errors.
Product
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0965-2026·2025-12-31
Infusion pump software feature failure may prevent review of medication library changes
ICU Medical's LifeShield Drug Library Management v2.2.1 has a nonfunctional Change Summary review feature for certain migrated customers. Users must use alternate methods to review library changes, or risk over-delivery, under-delivery, or setup delays.
Product
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
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-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-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-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-0331-2026·2025-11-05
ICU Medical Clave port weld may fail and cause drug leak
ICU Medical is recalling Clave Bag Spike devices (REF: CL2150) because the port weld may separate or break during use, potentially causing a medication leak.
Product
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
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-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-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
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-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