EXACTAMIX H938175Recalls & reported problems

Summary

The FDA's MAUDE database contains 263 adverse event reports that list this exact device (DI 00085412475806), received between Mar 9, 2018 and Jun 25, 2026 — classified as 263 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (225 reports).

3 FDA recall records name this device's identifier, 2 still open.

12 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.

Recalls naming this device

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 · 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-3084-2024 · Root cause: Other · FDA record ↗

3. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 263 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT EIGHTY ONE (81) VENTED MICRO-VOLUME INLETS HAD PARTICULATE ON THE TUBING AND INSIDE THE PACKAGING. THE PARTICLES WERE IDENTIFIED DURING A VISUAL INSPECTION AND PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25630514 ↗
• MalfunctionMay 27, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER (HAIR, PARTICLES, AND LINT) WAS OBSERVED IN THE OUTER PACKAGING, INSIDE THE INLET, AND/OR ON THE CONNECTORS OF TWO (02) VENTED MICRO VOLUME INLETS. ADDITIONALLY, THERE ARE INDICATIONS THAT HAIR, PARTICLES, OR LINT MAY ALSO BE PRESENT INSIDE THE INLET TUBING; HOWEVER, THIS CANNOT BE CONFIRMED WITH CERTAINTY DUE TO LIMITED VISIBILITY. THIS WAS DISCOVERED DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25298941 ↗
• MalfunctionMay 8, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER WAS FOUND ON THE INLETS INSIDE THE PACKAGING OF NINETY SEVEN (97) EXACTAMIX VENTED, MICRO-VOLUME INLETS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128877 ↗
• MalfunctionApr 17, 2026Contamination

  IT WAS REPORTED THAT FORTY-THREE (43) EXACTAMIX INLETS HAD PARTICULATE ON THE INLETS INSIDE THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915887 ↗
• MalfunctionApr 17, 2026Contamination

  IT WAS REPORTED THAT THIRTY-EIGHT (38) EXACTAMIX INLETS HAD PARTICULATE ON THE INLETS INSIDE THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24915828 ↗
• MalfunctionApr 16, 2026Contamination

  IT WAS REPORTED THAT PARTICULATE MATTER WAS OBSERVED IN THE OUTER PACKAGING, INLET, OR CONNECTORS OF TWELVE (12) EXACTAMIX INLETS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900014 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FIFTEEN (15) VENTED MICRO-VOLUME INLETS HAD PARTICULATE INSIDE THE PACKAGING. 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 24890892 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NINE (9) VENTED MICRO-VOLUME INLETS HAD PARTICULATE INSIDE THE PACKAGING. 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 24890467 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWENTY ONE (21) VENTED MICRO-VOLUME INLETS HAD PARTICULATE INSIDE THE PACKAGING. 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 24889953 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SIX (06) VENTED MICRO-VOLUME INLETS HAD PARTICULATE INSIDE THE PACKAGING. 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 24889771 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWENTY FIVE (25) VENTED MICRO-VOLUME INLETS HAD PARTICULATE INSIDE THE PACKAGING. 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 24889632 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NINETY THREE (93) VENTED MICRO-VOLUME INLETS HAD PARTICULATE INSIDE THE PACKAGING. 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 24889452 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SIXTEEN (16) VENTED MICRO-VOLUME INLETS HAD PARTICULATE INSIDE THE PACKAGING. 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 24889304 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SIXTY SEVEN (67) VENTED MICRO-VOLUME INLETS HAD PARTICULATE INSIDE THE PACKAGING. 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 24889109 ↗
• MalfunctionMar 6, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOUR (4) EXACTAMIX VENTED, MICRO-VOLUME INLETS HAD MOVABLE BLACK/WHITE PARTICLES AND FIBERS. THIS WAS OBSERVED DURING INSPECTION OF THE MATERIAL. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532750 ↗
• MalfunctionFeb 26, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN PARTICLES WERE FOUND IN THE PACKAGING OF AN UNSPECIFIED QUANTITY OF EXACTAMIX VENTED, MICRO-VOLUME INLETS. THE FOREIGN PARTICLES WERE OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457411 ↗
• MalfunctionFeb 26, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN PARTICLES WERE FOUND IN THE PACKAGING OF AN UNSPECIFIED QUANTITY OF EXACTAMIX VENTED, MICRO-VOLUME INLETS. THE FOREIGN PARTICLES WERE OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457407 ↗
• MalfunctionFeb 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWELVE (12) EXACTAMIX VENTED, MICRO-VOLUME INLETS HAD PARTICLES; FURTHER DESCRIBED AS " BLACK PARTICLE ON THE HOSE AREA". THE PARTICLES APPEARED TO BE FIXED. THIS WAS OBSERVED DURING INSPECTION, SHORTLY AFTER RECEIVING THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445882 ↗
• MalfunctionFeb 24, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PARTICULATE MATTER (PM) CONTAMINATION WAS OBSERVED ON THE TUBING AND IN THE BAG OF SEVEN (7) EXACTAMIX VENTED, MICRO-VOLUME INLETS. THE PM WAS DESCRIBED AS ¿BLACK SPOTS ON THE TUBES AND IN THE BAG¿. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430147 ↗
• MalfunctionFeb 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A VENTED MICRO-VOLUME INLET LEAKED AT THE CONNECTION OF THE "WHITE RUBBER CAP" AND THE TUBING. THIS OCCURRED DURING USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24417487 ↗
• MalfunctionFeb 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A VENTED MICRO-VOLUME INLET HAD PARTICULATE MATTER WHICH WAS DESCRIBED AS 'DARK MARKINGS ON THE SPIKE'. THIS WAS NOTICED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349474 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak; Component Missing

  IT WAS REPORTED THAT A VENTED MICRO-VOLUME INLET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260420 ↗
• MalfunctionFeb 2, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SEVENTY (70) NON-VENTED HIGH-VOLUME INLETS HAD PARTICULATE MATTER IN THE INLET. THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241729 ↗
• MalfunctionJan 30, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWELVE (12) VENTED MICRO-VOLUME INLETS HAD HAIRS, PARTICLES, AND LINT IN THE OUTER PACKAGING, THE INLET, AND/OR ON THE CONNECTORS. THIS OCCURRED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24227304 ↗
• MalfunctionJan 20, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWENTY-EIGHT (28) VENTED MICRO-VOLUME INLETS HAD PARTICLES IN AN UNSPECIFIED LOCATION. THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125369 ↗

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-3083-2024 · Aug 20, 2024 · Open, Classified
  Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, 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-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-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-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-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-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.