ICU Medical Recalls
657 recalls on record · August 8, 2012 to July 29, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Port REF: CL2100
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Bag Spike REF: CL-10
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/Che
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap,
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Re
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
November 5, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ChemoLock Bag Spike, 01 units REF: CL-10-10
Hazard: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
October 29, 2025Medical DevicesFDA
ICU Medical, Inc. recalls IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm
Hazard: 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.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubin
Hazard: 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.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 10
Hazard: 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.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 5
Hazard: 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.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper incl
Hazard: 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.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Produ
Hazard: 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.