MedexRecalls & reported problems across all models

We found 98 models of Medex by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 774 adverse event reports in the FDA's MAUDE database, received between Sep 14, 2016 and Sep 30, 2026 — classified as 57 injuries, 717 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (248 reports).

23 FDA recall records name at least one of these models by its device identifier, 23 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Medex recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0204-2025 · Root cause: Process control · Recall details · FDA record ↗

2. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0203-2025 · Root cause: Process control · Recall details · FDA record ↗

3. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0201-2025 · Root cause: Process control · Recall details · FDA record ↗

4. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0200-2025 · Root cause: Process control · Recall details · FDA record ↗

5. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0199-2025 · Root cause: Process control · Recall details · FDA record ↗

6. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0198-2025 · Root cause: Process control · Recall details · FDA record ↗

7. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0197-2025 · Root cause: Process control · Recall details · FDA record ↗

8. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0196-2025 · Root cause: Process control · Recall details · FDA record ↗

9. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0195-2025 · Root cause: Process control · Recall details · FDA record ↗

10. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0194-2025 · Root cause: Process control · Recall details · FDA record ↗

11. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0193-2025 · Root cause: Process control · Recall details · FDA record ↗

12. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0192-2025 · Root cause: Process control · Recall details · FDA record ↗

13. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0191-2025 · Root cause: Process control · Recall details · FDA record ↗

14. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0190-2025 · Root cause: Process control · Recall details · FDA record ↗

15. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0189-2025 · Root cause: Process control · Recall details · FDA record ↗

16. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0188-2025 · Root cause: Process control · Recall details · FDA record ↗

17. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0187-2025 · Root cause: Process control · Recall details · FDA record ↗

18. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0186-2025 · Root cause: Process control · Recall details · FDA record ↗

19. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0185-2025 · Root cause: Process control · Recall details · FDA record ↗

20. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0184-2025 · Root cause: Process control · Recall details · FDA record ↗

21. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0183-2025 · Root cause: Process control · Recall details · FDA record ↗

22. Sep 24, 2024Open, Classified

    Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

    Z-0182-2025 · Root cause: Process control · Recall details · FDA record ↗

23. Nov 10, 2023Open, Classified

    There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

    Z-0739-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Medex problems

Medex models

98 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Medex MX9505T

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall273 reports
• Medex MX9341L

  Stopcock, i.V. Set
  63 reports
• Medex MX9543

  Arterial blood sampling kit
  1 recall4 reports
• Medex MX7827

  Set, administration, intravascular
  1 recall1 report
• Medex MX9548

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX9547

  Arterial blood sampling kit
  1 recall0 reports
• Medex MX9545

  Arterial blood sampling kit
  1 recall0 reports
• Medex MX9544

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX9530T

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX950X2SC

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX950SCNT

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX950SCFT

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX9504T

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX9502T

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX9501T

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX950

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX20897

  DEVICE, MONITORING, INTRACRANIAL PRESSURE
  1 recall0 reports
• Medex MX20846R2

  Filter, infusion line
  1 recall0 reports
• Medex MX20740

  TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
  1 recall0 reports
• Medex MX20086

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex M20754

  TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
  1 recall0 reports
• Medex MXG300243R1

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MXG300260

  Arterial blood sampling kit
  1 recall0 reports
• Medex MX20103R1

  PROBE, BLOOD-FLOW, EXTRAVASCULAR
  1 recall0 reports
• Medex MX4705

  INFUSOR, PRESSURE, FOR I.V. BAGS
  36 reports
• Medex MX5341L

  Stopcock, i.V. Set
  30 reports
• Medex FS116

  Filter, infusion line
  30 reports
• Medex MX448HFB

  Filter, infusion line
  27 reports
• Medex MX43660

  Tubing, fluid delivery
  27 reports
• Medex MX4341L

  Stopcock, i.V. Set
  23 reports
• Medex MX960

  TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
  21 reports
• Medex MX9604A

  TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
  16 reports
• Medex MX4810

  INFUSOR, PRESSURE, FOR I.V. BAGS
  15 reports
• Medex MX43860

  Tubing, fluid delivery
  13 reports
• Medex MX5311L

  Stopcock, i.V. Set
  12 reports
• Medex MX2341L

  Stopcock, i.V. Set
  11 reports
• Medex MBF27

  Set, administration, intravascular
  11 reports
• Medex MX4805

  INFUSOR, PRESSURE, FOR I.V. BAGS
  9 reports
• Medex MX448F78MG

  Set, administration, intravascular
  8 reports
• Medex MX9605A

  TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
  6 reports
• Medex MX9342L

  Stopcock, i.V. Set
  6 reports
• Medex MX9311L

  Stopcock, i.V. Set
  6 reports
• Medex MX452FL

  Tubing, fluid delivery
  5 reports
• Medex MX451FL

  Tubing, fluid delivery
  5 reports
• Medex 537240PS

  Set, administration, intravascular
  5 reports
• Medex 536040

  Set, administration, intravascular
  5 reports
• Medex MX934Z3LM

  Stopcock, i.V. Set
  4 reports
• Medex MX560

  Set, administration, intravascular
  4 reports
• Medex MX493

  Set, administration, intravascular
  4 reports
• Medex MX4343LM

  Stopcock, i.V. Set
  4 reports
• Medex MX413SL

  Set, administration, intravascular
  4 reports
• Medex MX390

  Syringe, balloon inflation
  4 reports
• Medex MX1390

  Syringe, balloon inflation
  4 reports
• Medex MX458L

  Tubing, fluid delivery
  3 reports
• Medex MX453

  Set, administration, intravascular
  3 reports
• Medex MX450FL

  Tubing, fluid delivery
  3 reports
• Medex MX4345LM

  Stopcock, i.V. Set
  3 reports
• Medex MX412SL

  Set, administration, intravascular
  3 reports
• Medex MX252L

  Stopcock, i.V. Set
  3 reports
• Medex MTF37

  Set, administration, intravascular
  3 reports
• Medex M20178R2

  TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
  3 reports
• Medex FS113

  Filter, infusion line
  3 reports
• Medex 292004

  Cuff, tracheal tube, inflatable
  3 reports
• Medex MX934Z4LM

  Stopcock, i.V. Set
  2 reports
• Medex MX694R

  Set, administration, intravascular
  2 reports
• Medex MX693R

  Set, administration, intravascular
  2 reports
• Medex MX6812

  Set, administration, intravascular
  2 reports
• Medex MX613H

  Set, administration, intravascular
  2 reports
• Medex MX5341LN

  Stopcock, i.V. Set
  2 reports
• Medex MX522L

  Set, administration, intravascular
  2 reports
• Medex MX4710

  INFUSOR, PRESSURE, FOR I.V. BAGS
  2 reports
• Medex MX4342LM

  Stopcock, i.V. Set
  2 reports
• Medex MX4315LM

  Stopcock, i.V. Set
  2 reports
• Medex MX4311L

  Stopcock, i.V. Set
  2 reports
• Medex MX2311L

  Stopcock, i.V. Set
  2 reports
• Medex BF100

  Set, administration, intravascular
  2 reports
• Medex TF55

  Set, administration, intravascular
  1 report
• Medex SM5009

  Filter, infusion line
  1 report
• Medex MX960XY

  TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
  1 report
• Medex MX7961

  Set, administration, intravascular
  1 report
• Medex MX7624

  Set, administration, intravascular
  1 report
• Medex MX5342L

  Stopcock, i.V. Set
  1 report
• Medex MX522SL

  Set, administration, intravascular
  1 report
• Medex MX5096020MG

  Set, administration, intravascular
  1 report
• Medex MX497HP

  Set, administration, intravascular
  1 report
• Medex MX494

  Set, administration, intravascular
  1 report
• Medex MX453SL

  Set, administration, intravascular
  1 report
• Medex MX448L60MG

  Set, administration, intravascular
  1 report
• Medex MX448HLMG

  Set, administration, intravascular
  1 report
• Medex MX448HL60

  Tubing, fluid delivery
  1 report
• Medex MX448HL

  Tubing, fluid delivery
  1 report
• Medex MX4313FM

  Stopcock, i.V. Set
  1 report
• Medex MX4312L

  Stopcock, i.V. Set
  1 report
• Medex MX20119

  Set, administration, intravascular
  1 report
• Medex MX20108

  Set, administration, intravascular
  1 report
• Medex BTF36

  Set, administration, intravascular
  1 report
• Medex BBF26

  Set, administration, intravascular
  1 report
• Medex 53035

  Set, administration, intravascular
  1 report

Recent Medex adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949831 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937298 ↗
• MalfunctionSep 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931964 ↗
• MalfunctionSep 28, 2026Backflow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923282 ↗
• MalfunctionSep 25, 2026Air/Gas in Device

  It was reported that air was observed entering the line of the ULTRA¿ 4-Way Stopcock with Swivel Male Luer Lock, despite the connections being reported as secure. There was patient involvement; however, no patient harm or adverse event was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903500 ↗
• MalfunctionSep 25, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902236 ↗
• MalfunctionSep 24, 2026Break; Fluid/Blood Leak

  It was reported that, upon evaluation of the additionally received Medex Stopcocks, cracking was observed along the A-port shafts of the returned device. The reported defect was confirmed. There was patient involvement and moderate patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883606 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863041 ↗
• InjurySep 22, 2026Separation Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50861391 ↗
• MalfunctionSep 22, 2026Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859868 ↗
• MalfunctionSep 22, 2026Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859789 ↗
• MalfunctionSep 21, 2026Fluid/Blood Leak; Reflux within Device

  It was reported that blood refluxed into the tubing after connecting the transducer to the radial artery catheter. After replacing the transducer, blood return and leakage stopped. There was a patient involvement and there were no additional adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845233 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak; Reflux within Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829696 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak

  It was reported that blood was drawn via the right radial artery catheter. During flushing, leakage was observed at the sealed connection between the saline line and sensor. The consumable was replaced. There was a patient involvement and there were no additional adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818553 ↗
• MalfunctionSep 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747125 ↗

Other Icu Medical, Inc. products

• CADD123 models · 53,012 reports · 21 recalls
• Medfusion16 models · 13,114 reports · 5 recalls
• Bivona469 models · 2,811 reports · 29 recalls
• Level 152 models · 3,733 reports · 1 recall
• Portex409 models · 3,479 reports · 5 recalls
• Cleo6 models · 2,782 reports
• Pneupac23 models · 1,972 reports
• Plum26 models · 1,358 reports · 6 recalls