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.

226–250 of 657

  • HighFDA (Devices)·Z-0234-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets due to a potential manufacturing defect that may inhibit a proper seal.

    Product
    47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709121154(17)250101(30)25(10)4556714; (01)10887709121154(17)250101(30)25(10)4573639. The Intravascular Administration Set is a single u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0238-2021·2020-10-28

    ICU Medical Recalls NanoClave Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave intravascular administration sets because a manufacturing defect may prevent a proper seal with the spike.

    Product
    11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709069524(17)250201(30)50(10)4711196. The Intravascular Administration Set is a single use, s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0260-2021·2020-10-28

    ICU Medical Recalls 124 Inch Burette Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of 124-inch burette sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext. 1 unit per pouch, 25 pouches per case. UDI:(01)10887709034959(17)250201(30)25(10)4719728. The Intravascular Administration Set is a single use, sterile, n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0186-2021·2020-10-28

    ICU Medical Recalls Smallbore Extension Sets Due to Seal Defect

    ICU Medical is recalling specific lots of 7-inch smallbore extension sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709051048(17)250101(30)50(10)4572718; (01)10887709051048(17)250101(30)50(10)4603246; (01)10887709051048(17)250201(30)50(1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0220-2021·2020-10-28

    ICU Medical NanoClave Stopcock Manifold Recalled for Manufacturing Defect

    ICU Medical is recalling specific lots of NanoClave Stopcock Manifolds due to a potential manufacturing defect on the internal surface that may inhibit a proper seal with the NanoClave spike.

    Product
    Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887709053189(17)250101(30)50(10)4557545. The ICU Medical Clave Stopcock is a device used to admini
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0267-2021·2020-10-28

    ICU Medical Recalls NanoClave Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of NanoClave administration sets because a manufacturing defect may prevent the NanoClave from sealing properly.

    Product
    135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per pouch, 25 pouches per case. UDI:(01)10840619060616(17)250201(30)25(10)4711366. Administration sets and their accessories are single use, pre-sterilized devic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0202-2021·2020-10-28

    ICU Medical Recalls Smallbore Intravascular Administration Sets Due to Seal Defect

    ICU Medical is recalling specific lots of smallbore intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709075334(17)250101(30)50(10)4572784. The Intravascular Administration Set is a single us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0225-2021·2020-10-28

    ICU Medical Recalls Intravascular Administration Sets Due to Manufacturing Defect

    ICU Medical is recalling specific lots of intravascular administration sets because a manufacturing defect may prevent a proper seal.

    Product
    112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per case. UDI:(01)10887709088501(17)250201(30)25(10)4733705. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provid
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1270-2020·2020-05-27

    ICU Medical Recalls Lactated Ringer's Injection Due to Iron Oxide Particulates

    ICU Medical Inc. is recalling 93,648 units of Lactated Ringer's Injection due to confirmed iron oxide particulate matter.

    Product
    LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2001-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 235 Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2000-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect

    ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles. The defect prevents proper use of the device.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1999-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 60 units of Model 41406-23 Central Venous Catheters because the included guidewires cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41406-23
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1998-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-25.
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1996-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 20 Central Venous Catheters because the included guidewire cannot pass through the needles. The product was distributed to US consignees and Canada.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-2002-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

    ICU Medical is recalling 15 units of Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-1997-2020·2020-05-20

    ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect

    ICU Medical is recalling 260 units of Central Venous Catheters because the included guidewire cannot pass through the needles.

    Product
    Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41401-23.
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1912-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: B30211, 37" (94 cm) Appx 4.2 ml, 10 Drop Admin Set W/Luer Lock, Bag Hanger, Sterile R, UDI: (01)00887709063211
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1913-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 14,000 IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: B90240-50, 96" (244 cm) Appx 11.2 ml, 10 Drop Admin Set w/Coiled Tubing, Pre-Slit Port, Clave, Rotating Luer, Sterile R, UDI: (01)00887709077058
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1911-2020·2020-05-13

    ICU Medical Recalls Veterinary IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling veterinary IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of medication.

    Product
    REF: AH7117 111" 10 Drop Admin Set w/2 Inj Sites, Rotating Luer, Sterile R, For Veterinary Use Only, (01) 1 0887709 051475
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1920-2020·2020-05-13

    ICU Medical Recalls 10 Drop Primary IV Sets Due to Cannula Error

    ICU Medical is recalling 50 units of 10 Drop Primary IV Sets because they may contain 15 drops/mL cannulas, risking under-delivery of critical medications.

    Product
    REF: Z3806, 131" (333 cm) 10 Drop Primary Set w/2 MicroClave, Remv 4 Gang 4-way Stopcocks (1 Remv), Check Valve, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709059108
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-1915-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error

    ICU Medical is recalling 675 IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking under-delivery of critical medication.

    Product
    REF: MC330424, 145" (368 cm) Appx 19.8 ml, 10 Drop Primary Set w/4 MicroClave Clear, Remv 3-Way Stopcock, Rotating Luer, 1 Ext, Drop-In Ext Set w/Remv MicroClave Clear, Sterile R, UDI: (01)00887709088139
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1916-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 650 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.

    Product
    REF: Z2560, 100" 10 Drop Admin Set w/Hand Pump, 2 Clave", Rotating Luer, 1 Pressure Infusion (400psig) Ext, Purple Clamp, UDI: (01)(01)00887709026889
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1914-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 350 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.

    Product
    REF: B9900-287, 82" (208 cm) Appx 10.4 ml, 10 Drop Admin Set, w/Pre-Slit Port, Clave, 1 Ext, Rotating Luer, Sterile R, UDI: (01)00887709016842
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1917-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Potential Drop Cannula Error

    ICU Medical is recalling specific IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking inaccurate medication delivery.

    Product
    REF: Z2812, 121" 10 Drop Primary Set w/5 MicroClave, Remv 2 Gang 4-Way Stopcocks, Rotating Luer, 2 Ext, Sterile R, UDI: (01)00887709028074
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-1919-2020·2020-05-13

    ICU Medical Recalls IV Administration Sets with Incorrect Drop Cannula

    ICU Medical is recalling 275 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.

    Product
    REF: Z3239, 126" 10 Drop Primary Set w/3 MicroClave, 2 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile R, UDI: (01)00887709030473
    Category
    Medical Device
    Distribution
    44 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.