ICU Medical recalled the LifeShield Infusion Safety Software Suite v2.2 on November 24, 2025. The software fails to operate as expected for migrated libraries, risking medication delivery errors. The recall affects seven customers across several states, including California and New York.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical, Inc. or your healthcare provider for instructions. Notification method: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
LifeShield Infusion Safety Software Suite v2.2 is designed to manage drug libraries for infusion pumps, ensuring safe medication delivery. Healthcare providers use it to prevent medication errors during infusion therapies.
The software's malfunction prevents users from properly reviewing medication changes, which could lead to incorrect dosages being administered. This poses a significant risk to patient safety, particularly in critical care settings.
This recall is not part of a broader industry pattern.
The recall affects a small number of users, but those impacted may face serious risks associated with incorrect medication delivery. Immediate action is necessary to prevent potential harm.
You can find the software version and list number in the program settings or documentation provided during installation.
Expect a timeline of 4-6 weeks for refund processing or replacement.
Document all communications regarding the recall, including emails and receipts for the software.
The recall involves LifeShield Infusion Safety Software Suite v2.2, List Number 17003-02. This software was distributed nationwide in states such as California, Iowa, Louisiana, New York, Pennsylvania, Tennessee, and Virginia. It is designed for use with infusion pumps.
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet instant alerts for recalls that affect you. Free forever.
ICU Medical recalled 64,290 Pulsator Arterial Blood Sampling Kits due to a potential crack in the syringe collar. This defect may cause blood leakage and delayed sampling. The recall affects models sold nationwide since December 2025.
ICU Medical has recalled over 14 million needle-free access devices after reports of fluid leaks and potential exposure to biological contaminants. The recall affects devices distributed worldwide, including in 50 states and multiple countries. Users must stop using these devices immediately and follow recall instructions from the manufacturer.
ICU Medical recalled 64,290 spinal tray syringes on December 19, 2025, due to potential cracks in the syringe collar. The cracks may cause blood leakage and delays in blood draws or fluid delivery. Affected syringes were distributed nationwide across 13 states.
ICU Medical recalled Plum Duo Precision IV Pumps on December 15, 2025, after issues with programmed flush volumes could lead to violations. The recall affects models 400020403 in the U.S. and 400021003 in the Philippines. Users must stop using the device immediately and follow manufacturer instructions.
ICU Medical recalled 423 units of the Plum Duo Infusion System on December 15, 2025. Defective primary speakers may fail to produce audible alarms and alerts. This poses a high hazard risk to patients reliant on the device for medication administration.
ICU Medical recalled its Plum Solo and Duo Infusion pumps on December 15, 2025, after reports of programming errors. The pumps can fail to flush properly after piggyback therapy, posing a serious risk to patients. Healthcare providers must stop using these devices immediately and follow recall instructions.
ICU Medical recalled the Plum Duo Infusion Pump on December 15, 2025, after reports of malfunctioning flush programming. The recall affects models 400020401 and 400021001 sold worldwide. This issue may pose a high risk to patient safety.
ICU Medical recalled LifeShield Drug Library Management software on November 24, 2025. A software issue limits concentration precision to one decimal place, risking incorrect drug dosages. Users should stop using the product immediately and follow recall instructions.