ICU Medical Recalls
657 recalls on record · August 8, 2012 to July 29, 2026 · Drugs, Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 10, 2025Medical DevicesFDA
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product
Hazard: Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
August 13, 2025Medical DevicesFDA
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401
Hazard: ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
July 23, 2025Medical DevicesFDA
ICU Medical, Inc. recalls SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200
Hazard: Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
June 25, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Plum Solos, Item number 400011001; infusion pump
Hazard: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
June 25, 2025Medical DevicesFDA
ICU Medical, Inc. recalls ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump
Hazard: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
May 21, 2025Medical DevicesFDA
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Hazard: Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for therapy.
March 19, 2025DrugsFDA
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,
Hazard: Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
March 19, 2025DrugsFDA
ICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lak
Hazard: Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
December 18, 2024Medical DevicesFDA
ICU Medical, Inc. recalls ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environment
Hazard: Due to finished goods incorrectly packaged and labeled.
November 27, 2024Medical DevicesFDA
ICU Medical, Inc. recalls Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion
Hazard: ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.
August 21, 2024Medical DevicesFDA
ICU Medical Inc recalls Plum 360/A+ spare batteries. Item Number: SUB0000864.
Hazard: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
August 21, 2024Medical DevicesFDA
ICU Medical Inc recalls Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Number
Hazard: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
August 21, 2024Medical DevicesFDA
ICU Medical Inc recalls Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is
Hazard: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
August 30, 2023Medical DevicesFDA
ICU Medical Inc recalls Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 30
Hazard: Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
May 24, 2023Medical DevicesFDA
ICU Medical Inc recalls ASM Replacement Battery, Component Number SUB0000594
Hazard: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
May 24, 2023Medical DevicesFDA
ICU Medical Inc recalls ASM Replacement Battery, Component Number SUB0000864
Hazard: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
May 24, 2023Medical DevicesFDA
ICU Medical Inc recalls Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 1197
Hazard: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
May 24, 2023Medical DevicesFDA
ICU Medical Inc recalls Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
Hazard: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
November 23, 2022DrugsFDA
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 6
Hazard: Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
September 21, 2022Medical DevicesFDA
ICU Medical, Inc. recalls 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;
Hazard: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
September 21, 2022Medical DevicesFDA
ICU Medical, Inc. recalls 6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascu
Hazard: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
September 21, 2022Medical DevicesFDA
ICU Medical, Inc. recalls MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming
Hazard: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
September 21, 2022Medical DevicesFDA
ICU Medical, Inc. recalls 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
Hazard: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
September 21, 2022Medical DevicesFDA
ICU Medical, Inc. recalls 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotat
Hazard: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
September 21, 2022Medical DevicesFDA
ICU Medical, Inc. recalls MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed i
Hazard: Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
September 14, 2022Medical DevicesFDA
ICU Medical, Inc. recalls Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike
Hazard: Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
September 14, 2022Medical DevicesFDA
ICU Medical, Inc. recalls Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12
Hazard: Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.
September 22, 2021DrugsFDA
ICU Medical Inc recalls AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Fore
Hazard: Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
May 19, 2021Medical DevicesFDA
ICU Medical, Inc. recalls REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag
Hazard: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.