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.

1–25 of 657

  • HighFDA (Devices)·Z-2759-2026·2026-07-29

    ICU Medical Recalls Hotline Fluid Warming Sets Due to Leakage Risk

    ICU Medical is recalling specific lots of Hotline Fluid Warming Sets due to an increased likelihood of leakage from inadequate solvent application at the tubing to return connector bond.

    Product
    Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions, List Number L-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2724-2026·2026-07-22

    ICU Medical Plum Solo Precision IV Pump May Deliver Excess Medication

    ICU Medical is recalling the Plum Solo Precision IV Pump (v1.0.3) because in specific scenarios, the pump may fail to decrease the displayed volume and could deliver up to twice the programmed medication amount.

    Product
    ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2723-2026·2026-07-22

    ICU Medical Plum Duo Infusion Pump Software Defect Affecting Drug Delivery

    ICU Medical is recalling Plum Duo Infusion Pump v1.2.3 units due to a software defect that may cause the pump to deliver up to twice the programmed volume without decrementing the display, risking patient overdose.

    Product
    ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2313-2026·2026-06-17

    Plum Duo Precision IV pumps may not display soft limit alerts

    Plum Duo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.

    Product
    Plum Duo Precision IV Pump, 40002-0403
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2312-2026·2026-06-17

    Plum Duo infusion pumps may not display soft limit alerts

    Plum Duo Infusion Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.

    Product
    Plum Duo Infusion Pump, 40002-0401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2311-2026·2026-06-17

    Plum Solo Precision IV pumps may not display soft limit alerts

    Plum Solo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.

    Product
    Plum Solo Precision IV Pump, 40001-0401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2210-2026·2026-05-27

    Oncology Kit With Extension Sets May Leak During Infusion Therapy

    ICU Medical is recalling Oncology Kits with extension sets due to potential leaks that could interrupt chemotherapy infusion and expose hazardous substances to patients, caregivers, and pharmacy technicians.

    Product
    Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros; ChemoLock; Syringe Transfer Set w/MicroClave, ChemoLock Port, REF: CL3960
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2026·2026-01-28

    Needle free access connectors recalled over silicone seals that may tear

    ICU Medical is recalling 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the body or tear, which can cause fluid leaks, occluded flow or air infused into the body.

    Product
    Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2026·2026-01-28

    Plum Duo infusion pumps recalled over blocked piggyback flush programming

    ICU Medical is recalling the Plum Duo Infusion Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2026·2026-01-28

    Mini Cuban loaf cake with raisins recalled over undeclared FD&C Yellow 5

    Catao Market is recalling 260 master cases (3,120 loaf cakes) of Mini Gaceniga Authentic Cuban Loaf Cake Raisins because the colour FD&C Yellow #5 was not declared on the label.

    Product
    ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2026·2026-01-28

    Plum Solo pumps recalled over hard limit messages blocking flush programming

    ICU Medical is recalling the Plum Solo Precision IV Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2026·2026-01-21

    Infusion pumps recalled over speakers that may not produce audible alarms

    ICU Medical is recalling 423 Plum Duo Infusion Systems after one lot of defective primary speakers may fail to produce sound, so the pump may not produce audible alarms or alerts.

    Product
    Plum Duo Infusion System, List Number 40002-04-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2026·2026-01-21

    Arterial blood sampling kits recalled over a crack on the syringe collar

    ICU Medical is recalling 64,290 Pulsator Arterial Blood Sampling Kits because syringes may have a crack on the collar, which may lead to blood leakage and repeated draws.

    Product
    Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2026·2026-01-21

    Spinal tray syringes recalled over a crack on the syringe collar

    ICU Medical is recalling 64,290 Portex Spinal Trays because syringes may have a crack on the collar, which may lead to delayed or repeated blood draws and blood leakage.

    Product
    Portex Spinal Tray, Item No. A3729-24 A3595
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0966-2026·2025-12-31

    Infusion software recalled over concentration limits with insufficient decimal precision

    ICU Medical is recalling LifeShield Drug Library Management software because Concentration Limits can only be defined to one decimal place instead of three, which may result in over- or under-delivery.

    Product
    LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0965-2026·2025-12-31

    Infusion drug library software recalled over a failing change review option

    ICU Medical is recalling LifeShield Drug Library Management software because the Change Summary review option stops working for migrated libraries, which may lead to dosing or setup errors.

    Product
    LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0355-2026·2025-11-05

    Mini bag spike connectors recalled over port weld separation risk

    ICU Medical is recalling 400 ChemoLock connectors with Mini Bag Spike because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0343-2026·2025-11-05

    Universal vented vial spikes recalled over port weld separation risk

    ICU Medical is recalling 16,850 ChemoLock Universal Vented Vial Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2026·2025-11-05

    ChemosafeLock bag spikes recalled over port weld separation risk

    ICU Medical is recalling 134,700 ChemosafeLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0341-2026·2025-11-05

    Chemotherapy bag spikes recalled because port weld may separate and leak

    ICU Medical is recalling 7,850 ChemoLock Bag Spikes because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical ChemoLock Bag Spike REF: CL-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0360-2026·2025-11-05

    Graduated adapter extension sets recalled over port weld separation risk

    ICU Medical is recalling 5,700 7.5-inch extension sets with a ChemoLock port and graduated adapter because the port weld may separate or break during use and leak.

    Product
    ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2026·2025-11-05

    Six inch extension sets recalled because port weld may separate and leak

    ICU Medical is recalling 1,600 6-inch extension sets with MicroClave Clear and ChemoLock port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0336-2026·2025-11-05

    Oncology kits with ChemoLock port recalled over port weld separation

    ICU Medical is recalling 150 Oncology Kits with ChemoLock and ChemoLock Port because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0338-2026·2025-11-05

    Anti-siphon smallbore extension sets recalled over port weld separation risk

    ICU Medical is recalling 950 45-inch smallbore extension sets with an anti-siphon valve because the port weld of the drug transfer device may separate or break during use and leak.

    Product
    ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/ChemoLock Port, Rotating Luer REF: CL4151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2026·2025-11-05

    Purple cap administration sets recalled over port weld separation risk

    ICU Medical is recalling 11,000 31-inch administration sets with an integrated ChemoLock drip chamber because the port weld may separate or break during use and leak.

    Product
    ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
    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.