Icu Medical recalls
Icu Medical appears in 657 official U.S. recall notices indexed by RecallRadar.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176
FDA Device · Class II · 2025-11-05 · Icu Medical - 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…
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Port REF: CL2100
FDA Device · Class II · 2025-11-05 · Icu Medical - ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
FDA Device · Class II · 2025-11-05 · Icu Medical - IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359
FDA Device · Class I · 2025-10-29 · Icu Medical - Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer
FDA Device · Class II · 2025-09-10 · Icu Medical - Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and female…
FDA Device · Class II · 2025-09-10 · Icu Medical - Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer
FDA Device · Class II · 2025-09-10 · Icu Medical - Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer
FDA Device · Class II · 2025-09-10 · Icu Medical - Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer
FDA Device · Class II · 2025-09-10 · Icu Medical - Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer
FDA Device · Class II · 2025-09-10 · Icu Medical - Plum Duo Infusion System, List Number: 400020401
FDA Device · Class I · 2025-08-13 · Icu Medical - SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000
FDA Device · Class II · 2025-07-23 · Icu Medical - ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003
FDA Device · Class II · 2025-06-25 · Icu Medical - ICU Medical Plum Solos, Item number 400011001
FDA Device · Class II · 2025-06-25 · Icu Medical - LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
FDA Device · Class II · 2025-05-21 · Icu Medical - 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,…
FDA Drug · Class I · 2025-03-19 · Icu Medical - POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, US…
FDA Drug · Class I · 2025-03-19 · Icu Medical - ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants
FDA Device · Class II · 2024-12-18 · Icu Medical - Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List N…
FDA Device · Class I · 2024-11-27 · Icu Medical - Plum 360/A+ spare batteries
FDA Device · Class I · 2024-08-21 · Icu Medical - Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12…
FDA Device · Class I · 2024-08-21 · Icu Medical - Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
FDA Device · Class I · 2024-08-21 · Icu Medical - Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453,…
FDA Device · Class II · 2023-08-30 · Icu Medical - ASM Replacement Battery, Component Number SUB0000864
FDA Device · Class I · 2023-05-24 · Icu Medical - Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 126…
FDA Device · Class I · 2023-05-24 · Icu Medical - Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
FDA Device · Class I · 2023-05-24 · Icu Medical - ASM Replacement Battery, Component Number SUB0000594
FDA Device · Class I · 2023-05-24 · Icu Medical - 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC 0990…
FDA Drug · Class II · 2022-11-23 · Icu Medical - 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer
FDA Device · Class II · 2022-09-21 · Icu Medical - 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock
FDA Device · Class II · 2022-09-21 · Icu Medical - MicroClave Clear Neutral Connector
FDA Device · Class II · 2022-09-21 · Icu Medical - 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set
FDA Device · Class II · 2022-09-21 · Icu Medical - 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer
FDA Device · Class II · 2022-09-21 · Icu Medical - MicroClave Clear Neutral Connector
FDA Device · Class II · 2022-09-21 · Icu Medical - Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S
FDA Device · Class II · 2022-09-14 · Icu Medical - Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10
FDA Device · Class II · 2022-09-14 · Icu Medical - AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045
FDA Drug · Class I · 2021-09-22 · Icu Medical - REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vasc…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - Product Usage: prov…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a pati…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vas…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: p…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros , Bag Hanger, Drop-…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patien…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: pr…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros
FDA Device · Class II · 2021-05-19 · Icu Medical - REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container t…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and pat…
FDA Device · Class II · 2021-05-19 · Icu Medical - REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the administration of fluids f…
FDA Device · Class II · 2021-05-19 · Icu Medical