ICU Medical Inc
462 recalls on record · Latest: Jan 28, 2026
FDA Devices Moderate Jan 28, 2026
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Devices Moderate Jan 28, 2026
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
FDA Devices Moderate Jan 28, 2026
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Devices Moderate Jan 28, 2026
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Devices Moderate Jan 21, 2026
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
FDA Devices Moderate Dec 31, 2025
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
FDA Devices Moderate Dec 31, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
FDA Devices Moderate Nov 5, 2025
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
FDA Devices Moderate Nov 5, 2025
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
FDA Devices Moderate Nov 5, 2025
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
FDA Devices Moderate Nov 5, 2025
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
FDA Devices Moderate Nov 5, 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
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
FDA Devices Moderate Nov 5, 2025
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
FDA Devices Moderate Nov 5, 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
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
FDA Devices Moderate Nov 5, 2025
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
FDA Devices Moderate Nov 5, 2025
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemoLock Port REF: CL2100
FDA Devices Moderate Nov 5, 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…
FDA Devices Moderate Nov 5, 2025
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
FDA Devices Moderate Nov 5, 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 R…
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemoLock Bag Spike REF: CL-10
FDA Devices Moderate Nov 5, 2025
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
FDA Devices Moderate Nov 5, 2025
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
FDA Devices Moderate Nov 5, 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
FDA Devices Moderate Nov 5, 2025
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
FDA Devices Moderate Nov 5, 2025
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
FDA Devices Moderate Nov 5, 2025
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
FDA Devices Critical Oct 29, 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 …
FDA Devices Moderate Sep 10, 2025
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
FDA Devices Moderate Sep 10, 2025
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7302-24
FDA Devices Moderate Sep 10, 2025
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female NRFit co…
FDA Devices Moderate Sep 10, 2025
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
FDA Devices Moderate Sep 10, 2025
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code 21-7301-24
FDA Devices Critical Aug 13, 2025
Plum Duo Infusion System, List Number: 400020401
FDA Devices Moderate Jul 23, 2025
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
FDA Devices Moderate Jun 25, 2025
ICU Medical Plum Solos, Item number 400011001; infusion pump
FDA Drug Critical Mar 19, 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# 09…
FDA Drug Critical Mar 19, 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, US…
FDA Devices Moderate Dec 18, 2024
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The Chemolo…
FDA Devices Critical Aug 21, 2024
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618…
FDA Devices Critical May 24, 2023