ICU Medical Recalls

10 recalls found for ICU Medical. Check if any of your products are affected.

HIGHFDA DEVICE

ICU Medical Recalls Spinal Tray Syringes Due to Leakage Risk

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
Affected lots
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HIGHFDA DEVICE

ICU Medical Recalls Needles Free Access Devices Due to High Risk of Leakage

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
Needle free
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HIGHFDA DEVICE

ICU Medical Recalls Plum Duo IV Pump Due to High Hazard

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
Plum Solo
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HIGHFDA DEVICE

ICU Medical IV Pump Recalled Due to Programming Error Risk

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
Plum Solo
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HIGHFDA DEVICE

ICU Medical Recalls Plum Duo Infusion System Over Speaker Failure

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
ICU Medical
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HIGHFDA DEVICE

ICU Medical Recalls LifeShield Infusion Software Over Delivery Risk

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.

ICU Medical
For certain
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HIGHFDA DEVICE

ICU Medical Recalls LifeShield Infusion Safety Software Due to Risk

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.

ICU Medical
Software issue
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HIGHFDA DEVICE

ICU Medical Recalls IV Administration Sets Over High Hazard Risk

ICU Medical recalled 23,203 IV administration sets on October 2, 2025. The sets lack an internal shutoff valve, risking fluid over-delivery and air infusion. This recall affects devices distributed worldwide, including the U.S., Canada, Australia, and New Zealand.

ICU Medical
IV Gravity
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Brand Statistics

Total Recalls
10
Pages
1