The Recall Desk

Manufacturer

ICU Medical, Inc.

657 recalls in our database name ICU Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
657
Critical
2
Severe
51
Most recent
2026-07-29

Of the 657 recalls from ICU Medical, Inc. we have scored against our rubric, 2 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 51 (8%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

601–625 of 657

  • HighFDA (Devices)·Z-2165-2014·2014-08-13

    ICU Medical Recalls Transpac Arterial Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 50 units of Transpac arterial monitoring kits because a component connection may crack and cause a fluid leak.

    Product
    Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid press
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2157-2014·2014-08-13

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 20 units of Transpac IV Trifurcated Monitoring Kits because a component connection may crack, causing a fluid leak.

    Product
    Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and mont
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0679-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    8" Ext Set w/NanoClave" Stopcock, Clamp, Rotating Luer, Part No. A1000, Item No. AC102 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0694-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    7" (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7103-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administr
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-0683-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak. The affected units were distributed worldwide.

    Product
    7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula place
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0686-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector, Anti-Siphon Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. K7093-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0678-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Siphon Valve, Check Valve, 2 Clamps, Luer Lock, Part No. A1000, Item No. A1093 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular a
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0703-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B3304-T, Lot # 2791244. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of flui
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0692-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    10" (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7101-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration s
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0677-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2 Clamps, Rotating Luer, Part No. A1000, Item No. A1081 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration se
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0706-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClave¿ T-Connector, Rotating Luer, Item # A1003, Lot # 2773812. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administrat
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0661-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCVClave ¿, NanoClave¿ T-Connector, Rotating Luer, Part No. A1000, Item No. 011-A1094 The ICU Needleless Connector is a single use, sterile, non-pyro
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0685-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    10" (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connector, NanoClave" T-Connector, 4 Clamps (Red, White, Blue), Rotating Luer, Part No. A1000, Item No. K7091-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0671-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. A1052 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adminis
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0676-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    13" Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rotating Luer, Part No. A1000, Item No. A1080 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the admin
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0663-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive Filter, Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1097 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intend
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0699-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Leakage Risk

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    120" 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 2 Ext, Part No. A1000, Item No. SC125 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accesso
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0668-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.

    Product
    7" (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1009 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular adminis
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0674-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1071 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of flu
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0673-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of flui
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0669-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needlefree Connectors because a small percentage of the devices may leak.

    Product
    8" (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron Filter, NanoClave¿ T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. A1014 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intrav
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0695-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaks

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of devices may leak.

    Product
    11" Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave", 3 Clamps, Rotating Luer, Part No. A1000, Item No. K7105-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the adm
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0666-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.

    Product
    6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. A1001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the admi
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0693-2014·2014-01-15

    ICU Medical Recalls NanoClave Needleless Connectors Due to Potential Leaking

    ICU Medical is recalling specific lots of NanoClave Needleless Connectors because a small percentage of the devices may leak.

    Product
    10" (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7102-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0702-2014·2014-01-15

    ICU Medical Recalls NanoClave Needlefree Connectors Due to Potential Leaking

    ICU Medical is recalling NanoClave Needlefree Connectors because a small percentage of devices may leak.

    Product
    5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B3303-T, Lot # 2791243. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to
    Category
    Medical Device
    Distribution
    14 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

ICU Medical

California-based company that develops, manufactures, and sells medical technologies used in vascular therapy, oncology, and critical care applications

Country
United States
Founded
1984

Official website

Source: Wikidata (Q5969799), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.