Icu Medical, Inc.
Icu Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 1984, most recent 2026, with 640 FDA device recalls on record.
Top product codes for Icu Medical, Inc.
FDA recalls by Icu Medical, Inc.
10 most recent of 640- Z-2759-2026 — Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70
- Z-2723-2026 — ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
- Z-2724-2026 — ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
- Z-2313-2026 — Plum Duo Precision IV Pump, 40002-0403
- Z-2312-2026 — Plum Duo Infusion Pump, 40002-0401
- Z-2311-2026 — Plum Solo Precision IV Pump, 40001-0401
- Z-2210-2026 — Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
- Z-1100-2026 — Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
- Z-1111-2026 — Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
- Z-1101-2026 — Portex Spinal Tray, Item No. A3729-24 A3595
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Icu Medical, Inc.
- K252130 — LifeShield Infusion Safety Software Suite
- K252006 — OTTO Disinfecting Cap
- K251980 — ClaveQS Bag
- K250616 — Clave Neutral-Displacement Needlefree Connectors
- K242114 — Plum Solo Precision IV Pump
- K242115 — Plum Duo Precision IV Pump
- K242117 — LifeShield Infusion Safety Software Suite
- K243985 — Rio Drug Reconstitution Transfer Device
- K223606 — LifeShield Infusion Safety Software Suite
- K223607 — Plum Duo Infusion System
- K173477 — ChemoCLAVE Cytotoxic Medication Preparation and Delivery System
- K170110 — Diana Medication Transfer Set
- K152006 — Cogent Hemodynamic Monitoring System
- K151969 — Hospira Extension Sets
- K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
- K131549 — CHEMOLOCK, CHEMOLOCK PORT
- K100576 — HIGH PRESSURE SETS-400 PSI
- K100434 — CLAVE NEUTRON
- K090189 — ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE
- K082806 — SPINNING SPIROS, MODEL CH-2000
- K082836 — ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES
- K081361 — CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX
- K080007 — GRADUATED ADAPTER WITH CLAVE
- K080989 — UNIVERSAL VIAL ACCESS SPIKE
- K080077 — CLAVE STOPCOCK
- K070856 — ICU MEDICAL SINGLE-USE SYRINGE
- K070979 — PULL TAB SQUEEZE FLUSH
- K070633 — GENIE, MODEL CH-200
- K063784 — DYE MANAGEMENT SYSTEM
- K070532 — SPIROS
- K052594 — WILLCARE, MODEL GW-1020
- K053106 — TEGO, MODEL D1000
- K052865 — HOSPIRA CATH LAB CONVENIENCE KITS
- K051437 — CML 1000
- K042182 — Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
- K040710 — TEGO NEEDLE FREE ACCESS ACCESS DEVICE
- K041410 — PUNCTUR-GUARD WINGED SET FOR BLOOD COLLECTION, MODEL 5118
- K033290 — TALON INFUSION SET, MODEL IP XXXX
- K021692 — CLC2000 CATHETER PATENCY DEVICE
- K003513 — TAXOL ADMINISTRATION SET
- K000472 — POSI-LINK
- K983559 — BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
- K974589 — SMARTVALVE
- K973167 — POSITIVE PRESSURE CONNECTOR
- K972712 — CORE RESISTANT HUBER INFUSION SETS
- K970855 — CLAVE CONNECTOR
- K964435 — PRIMARY IV SET
- K954813 — ICU EXTENSION KIT
- K953573 — ICU STOPCOK WITH EXTENSION TUBING
- K941190 — CLAVE NEEDLE-LESS CONNECTOR OPEN EXTENSION SET
- K940296 — SAFE CONNECTOR
- K934591 — CLAVE VIAL ACCESS SPIKE
- K934561 — ONE TIME VIAL ACCESS SPIKE
- K921104 — LOPEZ VALVE WITH NG SUMP TUBE
- K915571 — CLAVE CONNECTOR
- K913476 — GI BLEEDER/OD SET
- K915171 — LOPEZ VALVE TM II
- K910546 — PIGGY LOCK NEEDLE HOUSING
- K881201 — HR VACUTRAC
- K881666 — HR(TM) INTRAVASCULAR CATHETER
- K874372 — HR(TM) NEEDLE AND SYRINGE
- K872580 — HR (TM) COLLECTION SYSTEM
- K861586 — LOPEZ VALVE
- K860781 — ICU MEDICAL NEEDLE, LOPEZ NEEDLE
- K853275 — CLICK LOCK MULTI-VAS INFECTION CONTROL MANIFOLD
- K840273 — LOPEZ LOCK
Data sourced from openFDA. This site is unofficial and independent of the FDA.