ICU Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
650 (28 Class I)
510(k) Clearances
71
Inspections
31
Compliance Actions
4

Recent Recalls

NumberClassProductDate
Z-1100-2026Class IIPulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PGDecember 19, 2025
Z-1111-2026Class IITego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000December 19, 2025
Z-1101-2026Class IIPortex Spinal Tray, Item No. A3729-24 A3595December 19, 2025
Z-1094-2026Class IIPlum Duo Infusion System, List Number 40002-04-01December 15, 2025
Z-1118-2026Class IIICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)December 15, 2025
Z-1120-2026Class IIICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)December 15, 2025
Z-1119-2026Class IIICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)December 15, 2025
Z-0965-2026Class IILifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List NuNovember 24, 2025
Z-0966-2026Class IILifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product November 24, 2025
Z-0154-2026Class IIV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF:October 2, 2025
Z-0346-2026Class IIICU Medical ChemoLock Closed Vial Spike REF: CL-80September 8, 2025
Z-0349-2026Class IIICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82September 8, 2025
Z-0336-2026Class IIICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136September 8, 2025
Z-0344-2026Class IIICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70SSeptember 8, 2025
Z-0341-2026Class IIICU Medical ChemoLock Bag Spike REF: CL-10September 8, 2025
Z-0356-2026Class IIICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34September 8, 2025
Z-0352-2026Class IIICU Medical Graduated Connector w/ChemoLock Port REF: CL3900September 8, 2025
Z-0365-2026Class IIICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202September 8, 2025
Z-0348-2026Class IIICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5September 8, 2025
Z-0337-2026Class IIICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock PortSeptember 8, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K252130LifeShield Infusion Safety Software SuiteApril 2, 2026
K252006OTTO™ Disinfecting CapMarch 27, 2026
K251980ClaveQS™ BagMarch 20, 2026
K250616Clave™ Neutral-Displacement Needlefree ConnectorsJune 5, 2025
K242114Plum Solo™ Precision IV PumpApril 2, 2025
K242115Plum Duo™ Precision IV PumpApril 2, 2025
K242117LifeShield Infusion Safety Software SuiteApril 2, 2025
K243985Rio™ Drug Reconstitution Transfer DeviceJanuary 22, 2025
K232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSDecember 20, 2023
K223606LifeShield™ Infusion Safety Software SuiteAugust 24, 2023
K223607Plum Duo™ Infusion SystemAugust 24, 2023
K192154Rio Vial-to-Bag Drug Reconstitution DeviceApril 20, 2020
K190918SwabTip Male Disinfectant CapMarch 6, 2020
K190157Diana ChemoClave Transfer SetOctober 23, 2019
K173477ChemoCLAVE Cytotoxic Medication Preparation and Delivery SystemAugust 31, 2018
K170110Diana Medication Transfer SetAugust 10, 2018
K171346Sapphire SetsAugust 25, 2017
K152006Cogent Hemodynamic Monitoring SystemMay 5, 2016
K151969Hospira Extension SetsJanuary 19, 2016
K140129PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETERJuly 2, 2014