The Recall Desk

Manufacturer

ICU Medical, Inc.

666 recalls in our database name ICU Medical, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
666
Critical
2
Severe
60
Most recent
2026-09-23

Of the 666 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 60 (9%) 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 666

  • HighFDA (Devices)·Z-3156-2026·2026-09-23

    ICU Medical Recalls Plum Administration Sets Due to Drip Chamber Discoloration

    ICU Medical is recalling Plum administration sets because drip chambers may contain black specks or discolored PVC material. The presence of particulate matter in the fluid path has not been ruled out.

    Product
    Plum administration sets
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3212-2026·2026-09-23

    ICU Medical Recalls CADD Yellow Medication Cassette Reservoirs Due to Leakage

    ICU Medical is recalling 185,688 CADD Yellow Medication Cassette Reservoirs because they may leak medication at the connector joint, potentially interrupting therapy or causing exposure to harmful agents.

    Product
    CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3157-2026·2026-09-23

    ICU Medical Recalls IV Administration Sets with Drip Chamber Specks

    ICU Medical is recalling IV Non-Dedicated Gravity Administration Sets because black specks in the drip chamber may cause healthcare providers to delay therapy.

    Product
    IV Non-Dedicated Gravity Administration Sets with drip chambers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3158-2026·2026-09-23

    ICU Medical Recalls Oncology Sets with Drip Chamber Discoloration

    ICU Medical is recalling 107,800 oncology sets because drip chambers may contain black specks from the molding process, which could lead to product replacement and therapy delays.

    Product
    Oncology sets with drip chambers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3159-2026·2026-09-23

    ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration

    ICU Medical is recalling 28,550 oncology sets because drip chambers may contain black specks from the molding process. The discolored material does not enter the fluid path but may cause therapy delays.

    Product
    Oncology sets with drip chambers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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
  • 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-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
  • 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-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-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-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-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

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.