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.

651–657 of 657

  • HighFDA (Devices)·Z-0701-2014·2014-01-15

    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 # B33101-T, Lot # 2791358. 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-0675-2014·2014-01-15

    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
    87" (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron Filter, 4 Clamps, Rotating Luer, 2 Exts, Drop-In NanoClave¿, Part No. A1000, Item No. A1078 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-0055-2013·2012-10-17

    ICU Medical Recalls 3 Port Off Manifold Due to Component Commingling

    ICU Medical is recalling 60 units of a 3 Port Off Manifold waste system because a 60 drop micro drip chamber may have been included on a 20 drop macro drip set.

    Product
    3 PORT "OFF" MANIFOLD w/WASTE BAG, SYRINGE and DyePod¿, Part Number (Item #) AG8049-NS, Lot # 2528655. K914299. Waste system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2012·2012-08-08

    ICU Medical Recalls High Pressure Stopcocks Due to Molding Defect

    ICU Medical is recalling 4,625 High Pressure Stopcocks because a molding defect may cause side ports to become totally occluded.

    Product
    High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2012·2012-08-08

    ICU Medical Recalls 94-inch IV Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of 94-inch IV administration sets because a molding defect may cause side ports to become occluded.

    Product
    94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2012·2012-08-08

    ICU Medical Flush Kits Recalled for Stopcock Molding Defect

    ICU Medical is recalling Flush Kits with 3 Way Off Stopcocks due to a molding defect that may occlude side ports.

    Product
    Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2129-2012·2012-08-08

    ICU Medical Recalls Cardiac Catheterization Waste Management Systems

    ICU Medical is recalling Cardiac Catheterization Waste Management Systems due to a molding defect in a high pressure stopcock that could cause side ports to become occluded.

    Product
    Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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.