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.

301–325 of 657

  • ModerateFDA (Devices)·Z-2649-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 units of Y-Type Blood Sets because they were labeled as not containing DEHP, despite potentially containing small amounts.

    Product
    159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, 3 Pre-Pierced Ports, Luer Lock, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2648-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    143" (363 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Drop-In Ext w/3 Gang 4 Way Stopcocks, MicroClave¿, Luer Lock, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2652-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling

    ICU Medical is recalling specific blood tubing sets because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    125" (318 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 3 Gang 4-Way Stopcock w/Baseplate, Rotating Luer, 3 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2621-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Inaccurate DEHP Labeling

    ICU Medical is recalling 160,016 Y-Type Blood Sets because some were labeled as not containing DEHP, though they may contain small amounts.

    Product
    140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way Stopcock, Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2626-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, though they may contain small amounts.

    Product
    99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-fr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2639-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    128" (325 cm) Y-Type Blood Set with 170 Micron Filter, Hand Pump, 2 Clave¿, Removable 2 Gang (Blue, Yellow) 1o2¿ Manifold, Baseplate, 1 Ext, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2609-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    168 cm (66") 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2615-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    112" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-fre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2607-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood set units because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    185 cm (73") Blood Set w/200 Micron Filter, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdrawal of b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2633-2018·2018-08-15

    ICU Medical Recalls Bifuse Blood Sets Due to DEHP Labeling Error

    ICU Medical is recalling 160,016 Bifuse Blood Sets because they are labeled as DEHP-free but may contain small amounts of DEHP.

    Product
    125" (318 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2643-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling

    ICU Medical is recalling specific blood tubing sets labeled as DEHP-free because they may contain small amounts of the chemical.

    Product
    99" (251 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2635-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 105-inch Y-Type Blood Sets because some were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    105" (267 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, MicroClave¿ Clear, Rotating Luer, 1 Ext, Approx Priming Volume: 59.3 mL, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2610-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Inaccurate DEHP Labeling

    ICU Medical is recalling specific blood set accessories because they were labeled as not containing DEHP, even though the product may contain small amounts of the chemical.

    Product
    32" (81 cm) Appx 4.4 mL, 20 Drop Blood Set w/200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2618-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP.

    Product
    88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for need
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2627-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood tubing sets because they were labeled as not containing DEHP, despite potentially containing small amounts.

    Product
    120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2634-2018·2018-08-15

    ICU Medical Recalls Blood Administration Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    164" (417 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, Remv 4 Gang 4-Way Stopcocks w/Baseplate, 4 MicroClave¿ Clear, Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2622-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    84" Y-Type Blood Set w/170 Micron Filter, Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free withdr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2642-2018·2018-08-15

    ICU Medical Recalls Blood Administration Sets Due to DEHP Labeling Error

    ICU Medical is recalling 160,016 blood administration sets labeled as DEHP-free, though they may contain small amounts of DEHP.

    Product
    100" (254 cm) 20 Drop Y-Type Blood Admin Set w/200 Micron Filter, Hand Pump, 2 Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or veni
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2611-2018·2018-08-15

    ICU Medical Blood Set Recall for Incorrect DEHP Labeling

    ICU Medical is recalling blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers 160,016 units distributed in the US and internationally.

    Product
    32" (81 cm) Appx 4.4 mL Blood Set w/20 Drop 200 Micron Filter, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture devices for needle-free with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2619-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free because they may contain small amounts of DEHP.

    Product
    147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rotating Luer, 1 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2641-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling specific blood tubing sets labeled as DEHP-free that may contain small amounts of the chemical.

    Product
    88" (224 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, Clave¿, Rotating Luer w/Filter Cap, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2631-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood tubing sets because they are labeled as not containing DEHP, but may contain small amounts of the chemical.

    Product
    140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or ven
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2620-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP. The devices were distributed in the US and several international countries.

    Product
    135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or ven
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2628-2018·2018-08-15

    ICU Medical Recalls Blood Sets with Incorrect DEHP Labeling

    ICU Medical is recalling specific lots of Y-Type Blood Sets because they were labeled as DEHP-free but may contain small amounts of the chemical.

    Product
    121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer, 2 Ext, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2623-2018·2018-08-15

    ICU Medical Recalls Blood Sets With Incorrect DEHP Labeling

    ICU Medical is recalling 160,016 blood sets labeled as DEHP-free that may contain small amounts of DEHP. The recall covers devices distributed in the US and several international countries.

    Product
    84" (213 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Cylindrical Hand Pump, Clave¿, Rotating Luer, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use as an adjunct to blood tubing sets or venipuncture d
    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.