ICU Medical, Inc.: Medical Device Recalls in 2025

According to to data from the FDA, there were 46 medical device recalls made by ICU Medical, Inc. in 2025. See the details of the recalls below.

You can see similar recalls for other firms.

• LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
• LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
• ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
• ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
• 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
• ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
• ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
• ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
• 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
• ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
• ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
• ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
• ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
• ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
• 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
• ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
• ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
• ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
• ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
• ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
• 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, Rotating Luer, 1 Ext, REF: B9732; 80" (203 cm) Y-Type 150 ml, Burette Set (Clave, Shut-Off), w/3-Way Stopcock, Clave, Graduated Adapter, Rotating, Luer, 1 Ext, REF: B9733; 53 cm (21") Add-On 150 ml Burette Set (Clave, Shut-Off), Vented Cap, REF: 011-C7014
• SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
• ICU Medical Plum Solos, Item number 400011001; infusion pump
• ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
• LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
• ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
• ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
• ICU Medical ChemosafeLock Connecter REF: KL-FNU3
• ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
• ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
• ChemoLock Bag Spike, 01 units REF: CL-10-10
• ICU Medical ChemoLock Port REF: CL2100
• 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
• ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
• Plum Duo Infusion System, List Number: 400020401
• ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
• 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
• ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
• ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
• ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
• ICU Medical ChemoLock Bag Spike REF: CL-10
• ICU Medical ChemoLock Closed Vial Spike REF: CL-80
• ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
• ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
• ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
• ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173