EXACTAMIX H938724ERecalls & reported problems

Summary

The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 00085412475776), received between Jul 31, 2018 and Sep 9, 2026 — classified as 105 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (51 reports).

15 other recalls cover devices cleared under the same FDA submission (K002705); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50681143 ↗
• MalfunctionMay 26, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTION TO THE BAG OF AN EM2400 VALVE SET SUDDENLY BROKE OFF DURING FILLING WHILE THE SET WAS CONNECTED TO A COMPOUNDER. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25286446 ↗
• MalfunctionMar 31, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN EXACTAMIX 2400 VALVE SET HAD CONTAMINATION IN THE PIPE (TUBING). THIS WAS OBSERVED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24749659 ↗
• MalfunctionFeb 2, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT VALVE PORTS OF A THREE (3) EXACTAMIX 2400 VALVE SETS HAD PARTICULATE MATTER (PM) CONTAMINATION. THE PM WAS DESCRIBED AS ¿VALVE PORT WITH STAINS ON IT¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234609 ↗
• MalfunctionJan 16, 2026Disconnection; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT EVERYTHING THAT CONNECTED TO THE BASE OF ELEVEN (11) EM2400 VALVE SETS BECAME DETACHED AND/OR LEAKED, LETTING AIR INTO THE SYSTEM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100974 ↗
• MalfunctionJan 2, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF EM2400 VALVE SET BROKE JUST ABOVE THE BAG-TUBING CONNECTION; THE "ISOLATOR" WAS SPRAYED WITH LIQUID. THE EVENT OCCURRED DURING PRODUCTION. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951800 ↗
• MalfunctionDec 4, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) CONTAMINATION WAS OBSERVED ON AN EXACTAMIX 2400 VALVE SET. THE PM WAS DESCRIBED AS, ¿A HAIR WAS NOTICED IN THE FILM/ON THE VALVE SET¿. THIS ISSUE WAS OBSERVED UPON UNPACKING THE STERILELY PACKAGED VALVE SET FROM ITS OUTER FILM. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716614 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT TWO (02) EM2400 VALVE SETS LEAKED. THE ISSUE WAS FURTHER DESCRIBED AS, "LEAK ON THE VALVE STRIP". THIS OCCURRED DURING USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879883 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FIVE (05) EM2400 VALVE SETS LEAKED. THE ISSUE WAS FURTHER DESCRIBED AS, "LEAK ON THE VALVE STRIP". THIS OCCURRED DURING USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879855 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EM2400 VALVE SET LEAKED. THE ISSUE WAS FURTHER DESCRIBED AS, "LEAK ON THE VALVE STRIP". THIS OCCURRED DURING USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879849 ↗
• MalfunctionAug 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EM2400 VALVE SET LEAKED. THE ISSUE WAS FURTHER DESCRIBED AS, "LEAK ON THE VALVE STRIP". THIS OCCURRED DURING USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879848 ↗
• MalfunctionJul 30, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EM2400 VALVE SET LEAKED FROM THE TUBING. THE ISSUE WAS FURTHER DESCRIBED AS, THE TUBING SUBSEQUENTLY BROKE. THIS OCCURRED WHEN THE SET WAS CONNECTED TO THE EM2400 PUMP, DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22664782 ↗
• MalfunctionJul 18, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT AN EXACTAMIX 2400 VALVE SET LEAKED FROM "PORT 1". THIS WAS DISCOVERED DURING USE OF THE DEVICE, WHEN AN UNINTENDED INGREDIENT WAS FOUND IN THE FINAL PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543125 ↗
• MalfunctionJun 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 2400 VALVE SET WAS LEAKING FROM PORT 1. THE LEAK CONTRIBUTED TO THE PREPARED BAGS BEING CONTAMINATED WITH THE COMPONENTS AT PORT 1 (WATER SOLUBLE VITAMINS). THE VALVE STRIP WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212854 ↗
• MalfunctionJun 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT UNSPECIFIED QUANTITY OF EM2400 VALVE SETS LEAKED DURING COMPOUNDING. IN ONE INSTANCE, THE LEAKAGE RESULTED IN CONTAMINATION OF PREPARED BAGS CONTAINING WATER-SOLUBLE VITAMINS AT PORT 1. THE VALVE SETS WERE REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212640 ↗
• MalfunctionJun 16, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EXACTAMIX 2400 VALVE SET WAS LEAKING FROM PORT 1. THE LEAK CONTRIBUTED TO THE PREPARED BAGS BEING CONTAMINATED WITH THE COMPONENTS AT PORT 1 (WATER SOLUBLE VITAMINS). THE VALVE STRIP WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212478 ↗
• MalfunctionMay 22, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN EM2400 VALVE SET HAD FLUID AT ONE OF THE "COUPLINGS" (VALVE PORTS). THIS WAS NOTICED WHEN REMOVING THE PROTECTIVE COVERS TO CONNECT THE VALVE SET TO THE COMPOUNDER DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075036 ↗
• MalfunctionApr 25, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED ONE EM2400 VALVE SET HAD CONDENSATION ON THE TOP RIGHT OF THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914465 ↗
• MalfunctionMar 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 2400 VALVE SETS WERE LEAKING. DURING COMPOUNDING, LIPID INJECTABLE EMULSION WAS OBSERVED LEAKING INTO PORTS 10/11 (NACL 30% AND KCL 15%) AND ON OCCASION 15/16 (STANDARD AMINO ACID SOLUTIONS). THESE LEAKS TRAVEL UPSTREAM SLOWLY TOWARDS THE CONTAINER AND OCCUR ONLY WHEN LIPID INJECTABLE EMULSION IS THE UI AND COMPOUNDING ALL-IN-ONE BAGS. THESE ISSUES OCCURRED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556313 ↗
• MalfunctionMar 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 2400 VALVE SETS WERE LEAKING. DURING COMPOUNDING, LIPID INJECTABLE EMULSION WAS OBSERVED LEAKING INTO PORTS 10/11 (NACL 30% AND KCL 15%) AND ON OCCASION 15/16 (STANDARD AMINO ACID SOLUTIONS). THESE LEAKS TRAVEL UPSTREAM SLOWLY TOWARDS THE CONTAINER AND OCCUR ONLY WHEN LIPID INJECTABLE EMULSION IS THE UI AND COMPOUNDING ALL-IN-ONE BAGS. THESE ISSUES OCCURRED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556312 ↗
• MalfunctionMar 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 2400 VALVE SETS WERE LEAKING. DURING COMPOUNDING, LIPID INJECTABLE EMULSION WAS OBSERVED LEAKING INTO PORTS 10/11 (NACL 30% AND KCL 15%) AND ON OCCASION 15/16 (STANDARD AMINO ACID SOLUTIONS). THESE LEAKS TRAVEL UPSTREAM SLOWLY TOWARDS THE CONTAINER AND OCCUR ONLY WHEN LIPID INJECTABLE EMULSION IS THE UI AND COMPOUNDING ALL-IN-ONE BAGS. THESE ISSUES OCCURRED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556310 ↗
• MalfunctionMar 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 2400 VALVE SETS WERE LEAKING. DURING COMPOUNDING, LIPID INJECTABLE EMULSION WAS OBSERVED LEAKING INTO PORTS 10/11 (NACL 30% AND KCL 15%) AND ON OCCASION 15/16 (STANDARD AMINO ACID SOLUTIONS). THESE LEAKS TRAVEL UPSTREAM SLOWLY TOWARDS THE CONTAINER AND OCCUR ONLY WHEN LIPID INJECTABLE EMULSION IS THE UI AND COMPOUNDING ALL-IN-ONE BAGS. THESE ISSUES OCCURRED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556308 ↗
• MalfunctionMar 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 2400 VALVE SETS WERE LEAKING. DURING COMPOUNDING, LIPID INJECTABLE EMULSION WAS OBSERVED LEAKING INTO PORTS 10/11 (NACL 30% AND KCL 15%) AND ON OCCASION 15/16 (STANDARD AMINO ACID SOLUTIONS). THESE LEAKS TRAVEL UPSTREAM SLOWLY TOWARDS THE CONTAINER AND OCCUR ONLY WHEN LIPID INJECTABLE EMULSION IS THE UI AND COMPOUNDING ALL-IN-ONE BAGS. THESE ISSUES OCCURRED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556304 ↗
• MalfunctionMar 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF EXACTAMIX 2400 VALVE SETS WERE LEAKING. DURING COMPOUNDING, LIPID INJECTABLE EMULSION WAS OBSERVED LEAKING INTO PORTS 10/11 (NACL 30% AND KCL 15%) AND ON OCCASION 15/16 (STANDARD AMINO ACID SOLUTIONS). THESE LEAKS TRAVEL UPSTREAM SLOWLY TOWARDS THE CONTAINER AND OCCUR ONLY WHEN LIPID INJECTABLE EMULSION IS THE UI AND COMPOUNDING ALL-IN-ONE BAGS. THESE ISSUES OCCURRED DURING COMPOUNDING PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21556302 ↗
• MalfunctionFeb 24, 2025Free or Unrestricted Flow; Free or Unrestricted Flow

  IT WAS REPORTED THAT LIPIDS (LOCATED ON PORT 1 AND 2) APPEARED IN THE TUBING AT THE VALVE OUTLET OF AN EM2400 VALVE SET. THIS WAS NOTICED WHEN THE PUMP WAS STOPPED AND THE DOORS WERE NORMALLY CLOSED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21454200 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002705. One submission often covers many models, so check the product and lot details in each record.

• Z-2262-2026 · Apr 22, 2026 · Open, Classified
  Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product Description: Tubing sets with push-on connector on one end (to attach to the
• Z-3083-2024 · Aug 20, 2024 · Open, Classified
  Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
• Z-3082-2024 · Aug 20, 2024 · Open, Classified
  Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
• Z-3084-2024 · Aug 20, 2024 · Open, Classified
  Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
• Z-3085-2024 · Aug 20, 2024 · Open, Classified
  Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
• Z-1001-2024 · Dec 22, 2023 · Open, Classified
  Baxter Exactamix Pro 1200, REF EXM12DY
• Z-1002-2024 · Dec 22, 2023 · Open, Classified
  Baxter Exactamix Pro 2400, REF EXM24DY
• Z-1570-2022 · Jul 14, 2022 · Open, Classified
  The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one
• Z-1909-2018 · Apr 25, 2018 · Terminated
  Baxter EXACTAMIX Inlet, Vented, High-Volume Inlet, REF H938174 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used
• Z-1910-2018 · Apr 25, 2018 · Terminated
  Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used
• Z-1911-2018 · Apr 25, 2018 · Terminated
  Baxter EXACTAMIX Inlet, Syringe Inlet, REF H938176 Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding device used in the pharm
• Z-1908-2018 · Apr 25, 2018 · Terminated
  Baxter EXACTAMIX Inlet, Non-Vented, High-Volume Inlet, REF H938173 Product Usage: Exacta-Mix 2400 Compounding System Administration set is a disposable component of a compounding
• Z-1752-2013 · Jun 4, 2013 · Terminated
  ExactaMix 1200 and 2400 Compounders. Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
• Z-1197-2010 · Feb 10, 2010 · Terminated
  Exacta-Mix 2400 Valve Set, 24 - Port Valve Assembly, REF: 724, STERILE, 10 per box. Baxa Corporation, Englewood CO. Intended as tubing for use in compounding, used to connect up
• Z-0210-04 · Nov 7, 2003 · Terminated
  Exacta-Mix 2400 pharmacy compounding system.