⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

ICU Medical recalls - full list & free alerts

64 official U.S. recalls involving ICU Medical in the last 12 months, most recently on 2026-09-23.

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Full list (64)

ICU Medical, Inc.: Plum administration sets
Medical DevicesFDA (device) · 2026-09-23 · Class II
ICU Medical, Inc.: IV Non-Dedicated Gravity Administration Sets with drip chambers
Medical DevicesFDA (device) · 2026-09-23 · Class II
ICU Medical, Inc.: Oncology sets with drip chambers
Medical DevicesFDA (device) · 2026-09-23 · Class II
ICU Medical, Inc.: Oncology sets with drip chambers
Medical DevicesFDA (device) · 2026-09-23 · Class II
ICU Medical, Inc.: IV Sets with drip chambers
Medical DevicesFDA (device) · 2026-09-23 · Class II
ICU Medical, Inc.: IV Sets with drip chambers
Medical DevicesFDA (device) · 2026-09-23 · Class II
ICU Medical, Inc.: IV Sets with drip chambers
Medical DevicesFDA (device) · 2026-09-23 · Class II
ICU Medical, Inc.: IV Sets with drip chambers
Medical DevicesFDA (device) · 2026-09-23 · Class II
ICU Medical, Inc.: CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24
Medical DevicesFDA (device) · 2026-09-23 · Class II
ICU Medical Inc.: Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous
Medical DevicesFDA (device) · 2026-07-29 · Class II
ICU Medical, Inc.: ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Medical DevicesFDA (device) · 2026-07-22 · Class II
ICU Medical, Inc.: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
Medical DevicesFDA (device) · 2026-07-22 · Class II
ICU Medical, Inc.: Plum Solo Precision IV Pump, 40001-0401
Medical DevicesFDA (device) · 2026-06-17 · Class II
ICU Medical, Inc.: Plum Duo Infusion Pump, 40002-0401
Medical DevicesFDA (device) · 2026-06-17 · Class II
ICU Medical, Inc.: Plum Duo Precision IV Pump, 40002-0403
Medical DevicesFDA (device) · 2026-06-17 · Class II
ICU Medical, Inc.: Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer S
Medical DevicesFDA (device) · 2026-05-27 · Class II
ICU Medical, Inc.: Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Medical DevicesFDA (device) · 2026-01-28 · Class II
ICU Medical, Inc.: ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Medical DevicesFDA (device) · 2026-01-28 · Class II
ICU Medical, Inc.: ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Medical DevicesFDA (device) · 2026-01-28 · Class II
ICU Medical, Inc.: ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Medical DevicesFDA (device) · 2026-01-28 · Class II
ICU Medical, Inc.: Plum Duo Infusion System, List Number 40002-04-01
Medical DevicesFDA (device) · 2026-01-21 · Class II
ICU Medical Inc.: Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Medical DevicesFDA (device) · 2026-01-21 · Class II
ICU Medical Inc.: Portex Spinal Tray, Item No. A3729-24 A3595
Medical DevicesFDA (device) · 2026-01-21 · Class II
ICU Medical, Inc.: LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Medical DevicesFDA (device) · 2025-12-31 · Class II
ICU Medical, Inc.: LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Medical DevicesFDA (device) · 2025-12-31 · Class II
ICU Medical, Inc.: ChemoLock Bag Spike, 01 units REF: CL-10-10
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: 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
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: 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: CL3
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"; ChemoLock" Univers
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: 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, Rotatin
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Bag Spike REF: CL-10
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Port REF: CL2100
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp,
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Medical DevicesFDA (device) · 2025-11-05 · Class II
ICU Medical, Inc.: 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
Medical DevicesFDA (device) · 2025-10-29 · Class I