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.

551–575 of 657

  • HighFDA (Devices)·Z-2811-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because the SafeSet Reservoir and blood sampling components may leak.

    Product
    Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24" Tubing, Disposable Transducer, 03 mL Squeeze Flush, Macrodrip (Patient Mount), Item No. 42648-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 1,420 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Monitoring Kit with 2 SafeSet 84" Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2 Needleless Valves, Item No. 42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2812-2016·2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 760 Transpac IV Trifurcated Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84", 3.3mL Squeeze Flushes, 3 Disposable Transducers, Macrodrip (Pole Mount), Item No. 42650-06 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extrava
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2806-2016·2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Kits Due to Leak Risk

    ICU Medical is recalling 250 units of Transpac IV Trifurcated Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2822-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 10 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    5 Port OFF Manifold with Transpac IV, Item No. 46100-29 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical curre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2825-2016·2016-09-21

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 140 units of TP4 Kits with SafeSet Reservoirs due to a potential for leaks. The affected medical devices were distributed nationwide.

    Product
    TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by conve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2827-2016·2016-09-21

    ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 150 units of Transpac IV Trifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2824-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 100 units of Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak hazard.

    Product
    Transpac IV Monitoring Kit with SafeSet 84" Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless Valve, Item No. 46104-53 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2817-2016·2016-09-21

    ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk

    ICU Medical is recalling 110 units of Double Kit with SafeSet and 03mL Flush Device due to a potential for leak.

    Product
    Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2823-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

    ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46103-22 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2805-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 420 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak. The affected units were distributed nationwide in the US.

    Product
    Transpac IV Monitoring Kit with SafeSet 84inch Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless Valves, Item No. 011-42646-66 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces betwee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2815-2016·2016-09-21

    ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

    ICU Medical is recalling 10 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

    Product
    Monitoring Kit with 30mL Flush Device, Item No. 46076-15 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2808-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling specific Transpac IV Monitoring Kits because of a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Monitoring Kit with 2 SafeSet Blood Sampling Ports, 60" TUBING, Disposable Transducer, 3 ML Intraflo Flush, Macrodrip (Pole Mount), Item No. 42619-08 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2813-2016·2016-09-21

    ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

    ICU Medical is recalling 90 units of Transpac IV Trifurcated Monitoring Kits due to a potential for leaks in the SafeSet Reservoir and blood sampling components.

    Product
    Transpac IV Trifurcated Monitoring Kit with 84" SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves, Item No. 42650-66 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cathe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1368-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding Systems Due to Volume Accuracy Issues

    ICU Medical is recalling 47 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.

    Product
    Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues

    ICU Medical is recalling 3 units of the Diana Automated Compounding System because compounded volumes under 5ml may not meet accuracy specifications.

    Product
    Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1367-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues

    ICU Medical is recalling 4 units of the Diana Automated Compounding System because compounded volumes under 5ml may not meet accuracy specifications.

    Product
    Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1369-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues

    ICU Medical is recalling 49 units of the Diana Automated Compounding System because it may not meet accuracy specifications when mixing volumes under 5ml.

    Product
    Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1364-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding Systems for Accuracy Issues

    ICU Medical is recalling 36 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.

    Product
    Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1365-2016·2016-04-20

    ICU Medical Recalls Diana Automated Compounding Systems for Accuracy Issues

    ICU Medical is recalling 57 Diana Automated Compounding Systems because they may not accurately mix volumes under 5ml.

    Product
    Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2016·2016-04-06

    ICU Medical Recalls I.V. Infusion Sets with Potential Leak

    ICU Medical is recalling 215 I.V. infusion administration sets because a connection may develop a leak.

    Product
    30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Bag Hanger, Item No. 011-CL3511 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1261-2016·2016-04-06

    ICU Medical Recalls I.V. Infusion Sets with Potential Leak

    ICU Medical is recalling 400 units of I.V. infusion administration sets because the connection between the drip chamber and ChemoLock port may develop a leak.

    Product
    31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1259-2016·2016-04-06

    ICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk

    ICU Medical is recalling specific IV infusion administration sets with ChemoLock ports because the connection may develop a leak.

    Product
    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1254-2016·2016-04-06

    ICU Medical Recalls IV Administration Sets with ChemoLock Port Leak Risk

    ICU Medical is recalling specific IV administration sets because a connection may develop a leak. The sets are distributed in the US and several international locations.

    Product
    74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1258-2016·2016-04-06

    ICU Medical Recalls ChemLock I.V. Infusion Administration Sets

    ICU Medical is recalling specific I.V. infusion administration sets because a connection may develop a leak.

    Product
    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 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.