EXACTAMIXRecalls & reported problems across all models

We found 28 models of EXACTAMIX by Baxter Healthcare Corporation in the FDA's device registry (GUDID). Together they are named in 6,739 adverse event reports in the FDA's MAUDE database, received between Dec 29, 2017 and Sep 28, 2026 — classified as 5 injuries, 6,734 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4,237 reports).

13 FDA recall records name at least one of these models by its device identifier, 8 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

EXACTAMIX 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. Apr 22, 2026Open, Classified

   Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as electrolyte imbalance, metabolic instability, delayed recovery, etc.

   Z-2262-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Aug 20, 2024Open, Classified

   Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

   Z-3085-2024 · Root cause: Other · Recall details · FDA record ↗

3. Aug 20, 2024Open, Classified

   Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

   Z-3084-2024 · Root cause: Other · Recall details · FDA record ↗

4. Aug 20, 2024Open, Classified

   Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

   Z-3083-2024 · Root cause: Other · Recall details · FDA record ↗

5. Aug 20, 2024Open, Classified

   Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Product Codes H938173, H938174, H938175, H938176, used with the ExactaMix and ExactaMix Pro compounders. Particulate matter has been observed within the inlet primary packaging inlet components, including within the sterile fluid path tubing, before use.

   Z-3082-2024 · Root cause: Other · Recall details · FDA record ↗

6. Dec 22, 2023Open, Classified

   An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.

   Z-1002-2024 · Root cause: Device Design · Recall details · FDA record ↗

7. Dec 22, 2023Open, Classified

   An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This issue can result in redundant ingredient delivery of the requested overfill volume.

   Z-1001-2024 · Root cause: Device Design · Recall details · FDA record ↗

8. Jul 14, 2022Open, Classified

   There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets.

   Z-1570-2022 · Root cause: Process control · Recall details · FDA record ↗

9. Sep 18, 2019Terminated

   Potential ability to leak once used for compounding.

   Z-0167-2020 · Root cause: Process control · names 5 of these models · Recall details · FDA record ↗

10. Apr 25, 2018Terminated

    Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

    Z-1911-2018 · Root cause: Labeling Change Control · Recall details · FDA record ↗

11. Apr 25, 2018Terminated

    Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

    Z-1910-2018 · Root cause: Labeling Change Control · Recall details · FDA record ↗

12. Apr 25, 2018Terminated

    Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

    Z-1909-2018 · Root cause: Labeling Change Control · Recall details · FDA record ↗

13. Apr 25, 2018Terminated

    Specific lots of EXACTAMIX Inlets listed below due to incorrectly performed over-labeling. The inlets were over-labeled with a blank label, or with a label containing an extended expiration date. If the product is used beyond the expiration date,

    Z-1908-2018 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported EXACTAMIX problems

EXACTAMIX models

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

• EXACTAMIX H938740

  Set, i.V. Fluid transfer
  1 recall1,350 reports
• EXACTAMIX H938738

  Set, i.V. Fluid transfer
  1 recall1,180 reports
• EXACTAMIX H938739

  Set, i.V. Fluid transfer
  1 recall972 reports
• EXACTAMIX H938741

  Set, i.V. Fluid transfer
  1 recall710 reports
• EXACTAMIX H938737

  Set, i.V. Fluid transfer
  1 recall607 reports
• EXACTAMIX H938724

  Set, i.V. Fluid transfer
  1 recall513 reports
• EXACTAMIX H938175

  SYSTEM/DEVICE, PHARMACY COMPOUNDING
  3 recalls263 reports
• EXACTAMIX H938173

  Set, i.V. Fluid transfer
  2 recalls260 reports
• EXACTAMIX H938174

  SYSTEM/DEVICE, PHARMACY COMPOUNDING
  2 recalls238 reports
• EXACTAMIX H938176

  Set, i.V. Fluid transfer
  2 recalls232 reports
• EXACTAMIX H938724E

  Set, i.V. Fluid transfer
  105 reports
• EXACTAMIX H938742

  Set, i.V. Fluid transfer
  93 reports
• EXACTAMIX H938743

  Set, i.V. Fluid transfer
  87 reports
• EXACTAMIX EXM24DY

  System/device, pharmacy compounding
  1 recall0 reports
• EXACTAMIX EXM12DY

  System/device, pharmacy compounding
  1 recall0 reports
• EXACTAMIX H938751

  Set, i.V. Fluid transfer
  40 reports
• EXACTAMIX H938905

  CONTAINER, I.V.
  31 reports
• EXACTAMIX H9382400-M

  SYSTEM/DEVICE, PHARMACY COMPOUNDING
  15 reports
• EXACTAMIX H938792

  Set, i.V. Fluid transfer
  12 reports
• EXACTAMIX EXACTA-M

  System/device, pharmacy compounding
  11 reports
• EXACTAMIX H93884

  Syringe, piston
  7 reports
• EXACTAMIX EXACTA24-DYR

  System/device, pharmacy compounding
  3 reports
• EXACTAMIX H93867

  Set, i.V. Fluid transfer
  3 reports
• EXACTAMIX H9382400-L

  SYSTEM/DEVICE, PHARMACY COMPOUNDING
  2 reports
• EXACTAMIX EXACTA24-DY

  System/device, pharmacy compounding
  2 reports
• EXACTAMIX H938735

  Set, i.V. Fluid transfer
  1 report
• EXACTAMIX H9382400-MR

  SYSTEM/DEVICE, PHARMACY COMPOUNDING
  1 report
• EXACTAMIX H9382400-DY

  SYSTEM/DEVICE, PHARMACY COMPOUNDING
  1 report

Recent EXACTAMIX adverse event reports

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

• MalfunctionSep 28, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923573 ↗
• MalfunctionSep 23, 2026Device Emits Odor

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875525 ↗
• MalfunctionSep 23, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875490 ↗
• MalfunctionSep 22, 2026Fluid/Blood Leak

  It was reported that three (3) EXACTAMIX Empty EVA Bag 500 mL leaked at the membrane port. The issue was identified during the compounding process, prior to patient use. The bags contained ISS solution, Parenteral Nutrition solution, and narcotic solution. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856410 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809254 ↗
• MalfunctionSep 17, 2026Fluid/Blood Leak

  It was reported that four (4) ExactaMix 1000 mL EVA TPN Bags leaked from the administration port. This occurred during setup and preparation. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50797528 ↗
• MalfunctionSep 16, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794593 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50782150 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781560 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  It was reported that an ExactaMix 500 mL EVA TPN Bag leaked from the injection port. The issue was identified during setup. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766796 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  It was reported that an ExactaMix 1000 ml EVA TPN Bag leaked from the administration port. This occurred during an unspecified process step. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766628 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak

  It was reported that ten (10) ExactaMix 500 mL EVA TPN Bags leaked liquid from the membrane port. This occurred during the compounding process, prior to patient use. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758081 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak

  It was reported that an ExactaMix 2000 mL EVA TPN Bag leaked at the injection site. This occurred during preparation, prior to patient use. There was no patient involvement. No additional information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754044 ↗
• MalfunctionSep 11, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740050 ↗
• MalfunctionSep 11, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725181 ↗

Other Baxter Healthcare Corporation products

• MiniCap3 models · 3,423 reports · 7 recalls
• Novum IQ3 models · 1,540 reports · 7 recalls
• CLEARLINK/CONTINU-FLO/DUO-VENT3 models · 873 reports · 3 recalls
• CLEARLINK19 models · 710 reports · 4 recalls
• CLEARLINK/CONTINU-FLO8 models · 416 reports · 4 recalls
• CLEARLINK/DUO-VENT5 models · 282 reports · 1 recall
• REPEATER6 models · 189 reports
• DUO-VENT5 models · 31 reports · 2 recalls