ICU Medical, Inc. Recalls
67 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (65)
- Class II
March 24, 2026
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
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
- Class II
December 19, 2025
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
- Class II
December 19, 2025
Portex Spinal Tray, Item No. A3729-24 A3595
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
- Class II
December 19, 2025
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
- Class II
December 15, 2025
Plum Duo Infusion System, List Number 40002-04-01
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
- Class II
December 15, 2025
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- Class II
December 15, 2025
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- Class II
December 15, 2025
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
- Class II
November 24, 2025
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
- Class II
November 24, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
- Class I
October 2, 2025
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)
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
- Class II
September 8, 2025
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ChemoLock Bag Spike, 01 units REF: CL-10-10
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Port REF: CL2100
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Bag Spike REF: CL-10
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Universal Vented Vial Spike; Bag Hanger REF: CL3929
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
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
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
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
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
September 8, 2025
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
- Class II
August 6, 2025
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
- Class II
August 6, 2025
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included 100mL, Product Code 21-7300-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
- Class II
August 6, 2025
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
- Class II
August 6, 2025
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit connector. Yellow stopper included 100mL", Product C
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
- Class II
August 6, 2025
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
- Class II
August 6, 2025
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
- Class I
July 11, 2025
Plum Duo Infusion System, List Number: 400020401
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
- Class II
June 3, 2025
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
- Class II
May 2, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
- Class II
April 22, 2025
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
- Class II
April 22, 2025
ICU Medical Plum Solos, Item number 400011001; infusion pump
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
- Class II
November 6, 2024
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolock is needle free and cannot be deactivated, which
Due to finished goods incorrectly packaged and labeled.
- Class I
October 22, 2024
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.
- Class I
May 7, 2024
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
- Class I
May 7, 2024
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
- Class I
May 7, 2024
Plum 360/A+ spare batteries. Item Number: SUB0000864.
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Drug Recalls (2)
- Class I
February 13, 2025
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
- Class I
February 13, 2025
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.