Brand

Icu Medical Inc Recalls

441 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Icu Medical Inc.

441Total Recalls
20Critical
66.1MUnits Affected
Dec 19, 2025Most Recent
All Recalls

Every Icu Medical Inc Recall

Sorted by most recent. Click any recall for full details.

441 recalls
High RiskFDA
Icu Medical, Inc.
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Medical Devices·14,684,607 affected·Dec 19, 2025
High RiskFDA
Icu Medical Inc.
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
Medical Devices·64,290 affected·Dec 19, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Medical Devices·0 affected·Dec 15, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Medical Devices·0 affected·Dec 15, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
Medical Devices·0 affected·Dec 15, 2025
High RiskFDA
Icu Medical, Inc.
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
Medical Devices·7 affected·Nov 24, 2025
High RiskFDA
Icu Medical, Inc.
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
Medical Devices·12 affected·Nov 24, 2025
CriticalFDA
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 ...
Medical Devices·23,203 affected·Oct 2, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5
Medical Devices·8,475 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35
Medical Devices·2,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS
Medical Devices·2,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemosafeLock Connecter REF: KL-FNU3
Medical Devices·134,700 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34
Medical Devices·900 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20
Medical Devices·80 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10
Medical Devices·2,100 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360
Medical Devices·950 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955
Medical Devices·6,450 affected·Sep 8, 2025
High RiskFDA
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 Devices·11,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3
Medical Devices·202,900 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138
Medical Devices·600 affected·Sep 8, 2025
High RiskFDA
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: ...
Medical Devices·7,950 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S
Medical Devices·53,050 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900
Medical Devices·1,700 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150
Medical Devices·200 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Port REF: CL2100
Medical Devices·133,255 affected·Sep 8, 2025
High RiskFDA
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, Clam...
Medical Devices·200 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33
Medical Devices·4,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
Medical Devices·134,700 affected·Sep 8, 2025
High RiskFDA
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, Rota...
Medical Devices·950 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Bag Spike REF: CL-10
Medical Devices·7,850 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
Medical Devices·150 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock Closed Vial Spike REF: CL-80
Medical Devices·6,150 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
Medical Devices·2,450 affected·Sep 8, 2025
High RiskFDA
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 Devices·11,000 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82
Medical Devices·3,350 affected·Sep 8, 2025
High RiskFDA
Icu Medical, Inc.
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
Medical Devices·1,600 affected·Sep 8, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Medical Devices·29,811 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 100mL, Product Code...
Medical Devices·987,911 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubing, clamp and fem...
Medical Devices·15,546 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Product Code 21-7002-24
Medical Devices·265,500 affected·Aug 6, 2025
High RiskFDA
Icu Medical Inc.
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 50mL, Product Code...
Medical Devices·211,750 affected·Aug 6, 2025
CriticalFDA
Icu Medical, Inc.
Plum Duo Infusion System, List Number: 400020401
Medical Devices·4,677 affected·Jul 11, 2025
High RiskFDA
Icu Medical, Inc.
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Medical Devices·1,445,600 affected·Jun 3, 2025
CriticalFDA
Icu Medical, Inc.
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, ...
Drugs·0 affected·Feb 13, 2025
CriticalFDA
Icu Medical, Inc.
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinoi...
Drugs·67,488 affected·Feb 13, 2025
High RiskFDA
Icu Medical, Inc.
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. ...
Medical Devices·6,000 affected·Nov 6, 2024
CriticalFDA
Icu Medical Inc
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, ...
Medical Devices·14,744 affected·May 7, 2024
CriticalFDA
Icu Medical Inc
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Medical Devices·28,656 affected·Mar 22, 2023