ICU Medical, Inc. recalls

64 recalls on record · latest: March 24, 2026

Official U.S. recall history for ICU Medical, Inc., compiled from official government records.

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ICU Medical, Inc. recalls Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLoc…

March 24, 2026 · Medical device recalls Moderate risk Oncology sets/closed system transfer devices with extension sets may leak resul…

ICU Medical, Inc. recalls Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000

December 19, 2025 · Medical device recalls Moderate risk Needle free access device intended as accessory to vascular access used in hemo…

ICU Medical Inc. recalls Portex Spinal Tray, Item No. A3729-24 A3595

December 19, 2025 · Medical device recalls Moderate risk Affected lots of syringes may have a crack on the syringe collar, which may lea…

ICU Medical Inc. recalls Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG

December 19, 2025 · Medical device recalls Moderate risk Affected lots of syringes may have a crack on the syringe collar, which may lea…

ICU Medical, Inc. recalls ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)

December 15, 2025 · Medical device recalls Moderate risk Plum Solo and Duo Infusion pumps include a feature, that when selected, automat…

ICU Medical, Inc. recalls ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)

December 15, 2025 · Medical device recalls Moderate risk Plum Solo and Duo Infusion pumps include a feature, that when selected, automat…

ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)

December 15, 2025 · Medical device recalls Moderate risk Plum Solo and Duo Infusion pumps include a feature, that when selected, automat…

ICU Medical, Inc. recalls Plum Duo Infusion System, List Number 40002-04-01

December 15, 2025 · Medical device recalls Moderate risk ICU Medical received one lot of defective primary speakers from our supplier th…

ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02

November 24, 2025 · Medical device recalls Moderate risk Software issue only allows Concentration Limits to be defined to one digit of p…

ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02

November 24, 2025 · Medical device recalls Moderate risk For certain customers, the Change Summary review option ceases to operate as ex…

ICU Medical, Inc. recalls IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm) 1…

October 2, 2025 · Medical device recalls High risk IV Gravity burette administration set burette component is missing an internal…

ICU Medical, Inc. recalls ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ChemoLock Bag Spike, 01 units REF: CL-10-10

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"…

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger…

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock Closed Vial Spike REF: CL-80

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock Bag Spike REF: CL-10

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls 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…

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/Chem…

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock Port REF: CL2100

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, B…

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Re…

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemosafeLock Connecter REF: KL-FNU3

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical ChemoLock Port recalled over sterility concerns

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical, Inc. recalls ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5

September 8, 2025 · Medical device recalls Moderate risk Port weld of drug transfer device may separate or break during use and potentia…

ICU Medical Inc. recalls Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper inc…

August 6, 2025 · Medical device recalls Moderate risk Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weaken…

ICU Medical Inc. recalls Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included.…

August 6, 2025 · Medical device recalls Moderate risk Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weaken…

ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Produ…

August 6, 2025 · Medical device recalls Moderate risk Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weaken…

ICU Medical Inc. recalls Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubi…

August 6, 2025 · Medical device recalls Moderate risk Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weaken…

ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 1…

August 6, 2025 · Medical device recalls Moderate risk Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weaken…

ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product…

August 6, 2025 · Medical device recalls Moderate risk Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weaken…

ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401

July 11, 2025 · Medical device recalls High risk ICU Medical identified two sequences of programming events and alarm interactio…

ICU Medical, Inc. recalls SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000

June 3, 2025 · Medical device recalls Moderate risk Due to a manufacturing issue, disinfecting cap for needle-free connectors may h…

ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2

May 2, 2025 · Medical device recalls Moderate risk Firm has identified Drug Library Management defects in the software: 1) DLM sof…

ICU Medical, Inc. recalls ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump

April 22, 2025 · Medical device recalls Moderate risk Internal testing found that Plum Duo pumps with software version 1.1.1 have a w…

ICU Medical, Inc. recalls ICU Medical Plum Solos, Item number 400011001; infusion pump

April 22, 2025 · Medical device recalls Moderate risk Internal testing found that Plum Duo pumps with software version 1.1.1 have a w…

POTASSIUM CHLORIDE Inj recalled over labeling errors

February 13, 2025 · Drug & medication recalls High risk Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20…

ICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest,…

February 13, 2025 · Drug & medication recalls High risk Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chlor…

ICU Medical, Inc. recalls ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental…

November 6, 2024 · Medical device recalls Moderate risk Due to finished goods incorrectly packaged and labeled.

ICU Medical, Inc. recalls Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion…

October 22, 2024 · Medical device recalls High risk ICU Medical has received reports of allegedly counterfeit CSB batteries being u…