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ICU Medical, Inc.

ICU Medical, Inc. Recalls

All product recalls associated with ICU Medical, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 41–60 of 98 recalls

Plum Duo Infusion System (ICU Medical) – Interface Problem (2025)

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.

Moderate

FDAJul 11, 2025Nationwide• ICU Medical, Inc.

SwabCap Disinfecting Cap (ICU Medical) – Seal Integrity Issue (2025)

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.

Moderate

FDAJun 3, 2025Nationwide• ICU Medical, Inc.

LifeShield Infusion Software (ICU Medical) – Drug Library Defects (2025)

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.

1 234 5

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Moderate

FDAMay 2, 2025Nationwide• ICU Medical, Inc.

Plum Solos Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

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.

Moderate

FDAApr 22, 2025Nationwide• ICU Medical, Inc.

Plum Duo Infusion Pump (ICU Medical) – Dose Limit Bypass (2025)

Moderate

FDAApr 22, 2025Nationwide• ICU Medical, Inc.

Potassium Chloride Injection (ICU Medical) – Labeling Error (2025)

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 IHigh

FDAFeb 13, 2025Nationwide• ICU Medical, Inc.

Potassium Chloride Injection (ICU Medical) – Labeling Error (2025)

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 IHigh

FDAFeb 13, 2025Nationwide• ICU Medical, Inc.

ChemoLock Vial Spike (ICU Medical) – Packaging Error (2024)

Due to finished goods incorrectly packaged and labeled.

Moderate

FDANov 6, 2024Nationwide• ICU Medical, Inc.

Counterfeit Batteries (ICU Medical) – Battery Authenticity (2024)

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.

Moderate

FDAOct 22, 2024Nationwide• ICU Medical, Inc.

ICU Medical Inc: Replacement Battery List Number SUB0000864, found in Plum...

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.

Moderate

FDAMay 7, 2024Nationwide• ICU Medical Inc

ICU Medical Inc: Plum 360/A+ spare batteries. Item Number: SUB0000864.

Moderate

FDAMay 7, 2024Nationwide• ICU Medical Inc

ICU Medical Inc: Plum 360 Infusion System, List Numbers: 300100405, 30010...

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.

Moderate

FDAJul 13, 2023Nationwide• ICU Medical Inc

ICU Medical Inc: ASM Replacement Battery, Component Number SUB0000864

Moderate

FDAMar 22, 2023Nationwide• ICU Medical Inc

ICU Medical Inc: Replacement Battery List Number SUB0000864, found in Plum...

Moderate

FDAMar 22, 2023Nationwide• ICU Medical Inc

Sodium Chloride Injection (ICU Medical) – Sterility Compromise (2022)

Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

Class IIModerate

FDANov 9, 2022Nationwide• ICU Medical Inc