ICU Medical, Inc.

69 FDA enforcement actions

69 Total Recalls

9 Class I

60 Class II

0 Class III

Firm Details

Product Types: device, drug
States: CA, MN, IL

All Recalls

Class II: Risk 12/19/2025 device

Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
Class II: Risk 12/19/2025 device

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Class II: Risk 12/19/2025 device

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Class II: Risk 12/15/2025 device

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Class II: Risk 12/15/2025 device

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Class II: Risk 12/15/2025 device

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Class II: Risk 12/15/2025 device

ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
Class II: Risk 11/24/2025 device

For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
Class II: Risk 11/24/2025 device

Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
Class I: Dangerous 10/02/2025 device

IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in therapy during setup, over delivery/unrestricted flow, or air may be infused into the body.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 09/08/2025 device

Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class II: Risk 08/06/2025 device

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.
Class II: Risk 08/06/2025 device

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.
Class II: Risk 08/06/2025 device

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.
Class II: Risk 08/06/2025 device

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.
Class II: Risk 08/06/2025 device

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.
Class II: Risk 08/06/2025 device

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.
Class I: Dangerous 07/11/2025 device

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Class II: Risk 06/03/2025 device

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.
Class II: Risk 05/02/2025 device

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.
Class II: Risk 04/22/2025 device

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.
Class II: Risk 04/22/2025 device

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.
Class I: Dangerous 02/13/2025 drug

Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
Class I: Dangerous 02/13/2025 drug

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.
Class II: Risk 11/06/2024 device

Due to finished goods incorrectly packaged and labeled.
Class I: Dangerous 10/22/2024 device

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.
Class I: Dangerous 05/07/2024 device

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.
Class I: Dangerous 05/07/2024 device

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.
Class I: Dangerous 05/07/2024 device

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.
Class II: Risk 11/09/2022 drug

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Class I: Dangerous 09/03/2021 drug

Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Class II: Risk 03/09/2021 drug

Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.