FDA recall record · openFDA
ICU Medical, Inc.
75 FDA recalls on record (2023–2026) — 2 drug,73 device. 75 still ongoing.
12
Class I (most serious)
63
Class II
0
Class III
75
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Port weld of drug transfer device may separate or break during use and potentially result in a leak. 38
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in 7
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag per 6
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after 3
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit 3
Recalls
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Class I 2025-02-13 POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lak Class I 2025-02-13 Plum Duo Infusion System, List Number: 400020401 Class I 2025-07-11 IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm Class I 2025-10-02 Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Number Class I 2024-05-07 Plum 360/A+ spare batteries. Item Number: SUB0000864. Class I 2024-05-07 Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion Class I 2024-10-22 Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is Class I 2024-05-07 Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010 Class I 2023-03-22 ASM Replacement Battery, Component Number SUB0000864 Class I 2023-03-22 ASM Replacement Battery, Component Number SUB0000594 Class I 2023-03-22 Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 1197 Class I 2023-03-22 Plum Duo Precision IV Pump, 40002-0403 Class II 2026-04-29 Plum Duo Infusion Pump, 40002-0401 Class II 2026-04-29 Plum Solo Precision IV Pump, 40001-0401 Class II 2026-04-29 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock Class II 2026-03-24 Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Class II 2025-08-06 LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 Class II 2025-11-24 ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 Class II 2025-09-08 SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200 Class II 2025-06-03 ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 Class II 2025-09-08 ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS Class II 2025-09-08 ICU Medical ChemosafeLock Connecter REF: KL-FNU3 Class II 2025-09-08 ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 Class II 2025-09-08 ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20 Class II 2025-09-08 ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 Class II 2025-09-08 ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 Class II 2025-09-08 ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 Class II 2025-09-08 Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 10 Class II 2025-08-06 ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Re Class II 2025-09-08 ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3 Class II 2025-09-08 Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubin Class II 2025-08-06 ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138 Class II 2025-09-08 ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) Class II 2025-12-15 ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, Class II 2025-09-08 Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 Class II 2025-12-19 ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) Class II 2025-12-15 ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S Class II 2025-09-08 ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 Class II 2025-09-08 ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 Class II 2025-09-08 ICU Medical ChemoLock Port REF: CL2100 Class II 2025-09-08 ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/Chem Class II 2025-09-08 Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Produ Class II 2025-08-06 ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 Class II 2025-09-08 Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 5 Class II 2025-08-06 ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 Class II 2025-09-08 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 Class II 2025-09-08 ICU Medical ChemoLock Bag Spike REF: CL-10 Class II 2025-09-08 LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 Class II 2025-11-24 ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 Class II 2025-09-08 Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG Class II 2025-12-19 ICU Medical ChemoLock Closed Vial Spike REF: CL-80 Class II 2025-09-08 ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950 Class II 2025-09-08 ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger Class II 2025-09-08 ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines) Class II 2025-12-15 ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 Class II 2025-09-08 ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118 Class II 2025-09-08 ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176 Class II 2025-09-08 ICU Medical Plum Solos, Item number 400011001; infusion pump Class II 2025-04-22 Portex Spinal Tray, Item No. A3729-24 A3595 Class II 2025-12-19 ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 Class II 2025-09-08 ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock" Class II 2025-09-08 LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 Class II 2025-05-02 ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967 Class II 2025-09-08 Plum Duo Infusion System, List Number 40002-04-01 Class II 2025-12-15 ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 Class II 2025-09-08 ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S Class II 2025-09-08 ChemoLock Bag Spike, 01 units REF: CL-10-10 Class II 2025-09-08 ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173 Class II 2025-09-08 ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 Class II 2025-09-08 ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 Class II 2025-09-08 ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump Class II 2025-04-22 Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper incl Class II 2025-08-06 ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environment Class II 2024-11-06 Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 30 Class II 2023-07-13
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.