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.

626–650 of 657

  • HighFDA (Devices)·Z-0664-2014·2014-01-15

    ICU Medical Recalls NanoClave Stopcock Due to Potential Leakage

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

    Product
    NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 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 through a cannula placed in the v
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0697-2014·2014-01-15

    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
    8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7107-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the a
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0682-2014·2014-01-15

    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 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7088-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0665-2014·2014-01-15

    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
    17 cm (7'') Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating Luer, Part No. A1000, Item No. 011-AC103 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-0704-2014·2014-01-15

    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 devices may leak.

    Product
    28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating Luer, Item # B33071-T, Lot # 2791245. 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-0696-2014·2014-01-15

    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
    13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClave¿ Clear (Yellow, Red, Green Rings), 6 Clamps, Rotating Luer, Part No. A1000, Item No. K7106-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an acce
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0680-2014·2014-01-15

    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
    6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, Rotating Luer, Part No. A1000, Item No. K7084-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0707-2014·2014-01-15

    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
    17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. 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-0684-2014·2014-01-15

    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 devices may leak.

    Product
    7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave" T-Connector, Clamp, Rotating Luer, Part No. A1000, Item No. K7090-001 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-0698-2014·2014-01-15

    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
    30" (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector, Rotating Luer, 1 Ext, Part No. A1000, Item No. SC124 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0705-2014·2014-01-15

    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
    6.5" (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Purple Clamp, Rotating Luer, Item # A1099, Lot # 2791393. The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0658-2014·2014-01-15

    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
    NanoClave Connector, Part No. A1000, Item No. 011-A1000, 061-A1000, A1000, K7083-001, Z3769 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 pa
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0659-2014·2014-01-15

    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
    6" (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item No. 011-A1002 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the a
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0667-2014·2014-01-15

    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
    7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotating Luer, Part No. A1000, Item No. A1007 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0689-2014·2014-01-15

    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
    6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. K7096-001 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-0691-2014·2014-01-15

    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 devices may leak.

    Product
    7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. K7099-001 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
  • HighFDA (Devices)·Z-0687-2014·2014-01-15

    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. The affected units were distributed worldwide.

    Product
    78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connector, 4 Clamps, Rotating Luer, 3 Exts, Part No. A1000, Item No. K7094-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular ad
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0700-2014·2014-01-15

    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
    5" (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave", Clamp, Rotating Luer, Part No. A1000, Item No. Z3845 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administratio
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0681-2014·2014-01-15

    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
    6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector w/Luer Slip, Part No. A1000, Item No. K7085-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the ad
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0660-2014·2014-01-15

    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
    6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Rotating Luer, Part No. A1000, Item No. 011-A1029 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for th
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0688-2014·2014-01-15

    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 0.24 ml, Smallbore Ext Set w/NanoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7095-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0690-2014·2014-01-15

    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 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave", 3 Clamps, Luer Lock, Part No. A1000, Item No. K7097-001 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the ad
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0672-2014·2014-01-15

    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 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, Luer Lock, Part No. A1000, Item No. A1069 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-0670-2014·2014-01-15

    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
    78" Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave¿, NanoClave¿ T-Connector, 4 Clamps, Rotating Luer, 3 Ext, Part No. A1000, Item No. A1026 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-0662-2014·2014-01-15

    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
    184 cm (72") Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter, BCV-Clave¿, NanoClave¿ TConnector, Rotating Luer, Part No. A1000, Item No. 011-A1095 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for
    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.