Icu Medical recalls
Icu Medical appears in 657 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-29.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenou…
FDA Device · Class II · 2026-07-29 · Icu Medical - ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403
FDA Device · Class II · 2026-07-22 · Icu Medical - ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401
FDA Device · Class II · 2026-07-22 · Icu Medical - Plum Solo Precision IV Pump, 40001-0401
FDA Device · Class II · 2026-06-17 · Icu Medical - Plum Duo Precision IV Pump, 40002-0403
FDA Device · Class II · 2026-06-17 · Icu Medical - Plum Duo Infusion Pump, 40002-0401
FDA Device · Class II · 2026-06-17 · Icu Medical - Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros
FDA Device · Class II · 2026-05-27 · Icu Medical - ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
FDA Device · Class II · 2026-01-28 · Icu Medical - Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000
FDA Device · Class II · 2026-01-28 · Icu Medical - ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
FDA Device · Class II · 2026-01-28 · Icu Medical - ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
FDA Device · Class II · 2026-01-28 · Icu Medical - Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
FDA Device · Class II · 2026-01-21 · Icu Medical - Plum Duo Infusion System, List Number 40002-04-01
FDA Device · Class II · 2026-01-21 · Icu Medical - Portex Spinal Tray, Item No. A3729-24 A3595
FDA Device · Class II · 2026-01-21 · Icu Medical - LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
FDA Device · Class II · 2025-12-31 · Icu Medical - LifeShield Drug Library Management (DLM)
FDA Device · Class II · 2025-12-31 · Icu Medical - ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
FDA Device · Class II · 2025-11-05 · Icu Medical - 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 Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp,…
FDA Device · Class II · 2025-11-05 · Icu Medical - ChemoLock Bag Spike, 01 units REF: CL-10-10
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
FDA Device · Class II · 2025-11-05 · Icu Medical - 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 Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Bag Spike REF: CL-10
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Closed Vial Spike REF: CL-80
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemosafeLock Connecter REF: KL-FNU3
FDA Device · Class II · 2025-11-05 · Icu Medical - 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 Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
FDA Device · Class II · 2025-11-05 · Icu Medical