EXACTAMIX H938173Recalls & reported problems

Summary

The FDA's MAUDE database contains 260 adverse event reports that list this exact device (DI 00085412475783), received between May 25, 2018 and Sep 3, 2026 — classified as 260 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (241 reports).

2 FDA recall records name this device's identifier, 1 still open.

13 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. 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 · FDA record ↗

2. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 260 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50598977 ↗
• MalfunctionSep 2, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573447 ↗
• MalfunctionJun 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWO (2) NON-VENTED HIGH-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 25630882 ↗
• MalfunctionJun 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FORTY-EIGHT (48) NON-VENTED HIGH-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 25630881 ↗
• MalfunctionJun 25, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SIXTY SEVEN (67) NON-VENTED HIGH-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 25630770 ↗
• MalfunctionMay 19, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A NON-VENTED HIGH-VOLUME INLET HAD A FOREIGN PARTICLE IN THE PRODUCT CONTAINER (PACKAGING FACTOR 25 PIECES). THE ISSUE WAS DETECTED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218814 ↗
• MalfunctionApr 24, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT "REPEATED CORING" WAS OBSERVED DURING THE USE OF ELEVEN (11) EXACTAMIX NON-VENTED, HIGH-VOLUME INLETS. THESE EVENTS OCCURRED DURING TOTAL PARENTERAL NUTRITION (TPN) COMPOUNDING USING STERILE WATER FOR INJECTION (SWFI) AND 70% DEXTROSE. THE COMPLAINANT INDICATED THAT THAT THE CORING WAS NOTED IN NINE (9) 2 IN 1 PREPARATIONS AND TWO (2) 3 IN 1 PREPARATIONS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24989271 ↗
• MalfunctionApr 24, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT "CORING" WAS OBSERVED IN AN EXACTAMIX NON-VENTED, HIGH-VOLUME INLET DURING TOTAL PARENTERAL NUTRITION (TPN) COMPOUNDING USING STERILE WATER FOR INJECTION (SWFI) AND 70% DEXTROSE. IT WAS CONFIRMED THAT THE COMPOUNDED TPN BAG "REACHED A PATIENT; HOWEVER, NO INFORMATION WAS PROVIDED TO CONFIRM WHETHER THE BAG WAS ADMINISTERED TO A PATIENT¿. 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 24988954 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWENTY SEVEN (27) NON-VENTED HIGH-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 24888776 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT ELEVEN (11) NON-VENTED HIGH-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 24888472 ↗
• MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FIFTY SIX (56) NON-VENTED HIGH-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 24888227 ↗
• MalfunctionApr 8, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THREE (3) EXACTAMIX NON-VENTED, HIGH-VOLUME INLETS HAD A "DROPLET FORMED" ON THE SPIKE AREA. THIS WAS OBSERVED DURING VISUAL INSPECTION BEFORE OPENING THE OVERPOUCH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816284 ↗
• MalfunctionApr 8, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN EXACTAMIX NON-VENTED, HIGH-VOLUME INLET HAD A "DROPLET FORMED" ON THE SPIKE AREA. THIS WAS OBSERVED DURING VISUAL INSPECTION BEFORE OPENING THE OVER POUCH. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816105 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A NON-VENTED HIGH-VOLUME INLET LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760367 ↗
• MalfunctionMar 10, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A NON-VENTED HIGH-VOLUME INLET HAD HAIR INSIDE THE PACKAGING. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562828 ↗
• MalfunctionMar 6, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FIXED BLACK PARTICLES AND FIBERS WERE OBSERVED IN TWELVE (12) NON-VENTED HIGH-VOLUME INLETS. 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 24533898 ↗
• MalfunctionFeb 24, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN PARTICLES WERE FOUND IN THE PACKAGING OF AN UNSPECIFIED QUANTITY OF EXACTAMIX NON-VENTED, HIGH-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 24436160 ↗
• MalfunctionFeb 24, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN PARTICLES WERE FOUND IN THE PACKAGING OF AN UNSPECIFIED QUANTITY OF EXACTAMIX NON-VENTED, HIGH-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 24435791 ↗
• MalfunctionFeb 24, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN PARTICLES WERE FOUND IN THE PACKAGING OF AN UNSPECIFIED QUANTITY OF EXACTAMIX NON-VENTED, HIGH-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 24435514 ↗
• MalfunctionFeb 2, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWENTY (20) 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 24241095 ↗
• MalfunctionFeb 2, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT EIGHTEEN (18) 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 24240457 ↗
• MalfunctionFeb 2, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THIRTEEN (13) 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 24240068 ↗
• MalfunctionJan 26, 2026Air/Gas in Device

  IT WAS REPORTED THAT AIR WAS ENTERING THE SET AND INLET DURING THE USE OF AN EXACTAMIX NON-VENTED, HIGH-VOLUME INLET AND EXACTAMIX 2400 VALVE SET. BUBBLES WERE OBSERVED WHILE PUMPING BAGS IN THE PHARMACY PRIOR TO PATIENT USE. INTERMITTENT BUBBLES WERE OBSERVED POSSIBLY FROM THE CAL GLUCONATE. THE INLET WAS SWAPPED OUT ON THE DEXTROSE AND RAN DIRECT ENTRY 200ML DEXTROSE AND 200ML STERILE WATER WITH A BUBBLE DETECTED WHILE PUMPING DEXTROSE AND A 0.60% VARIANCE. IT APPEARED TO BE AN ISSUE WITH A LEAKY VALVE SET OR INLET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184646 ↗
• MalfunctionJan 20, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT TWENTY-NINE (29) NON-VENTED HIGH-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 24125103 ↗
• MalfunctionJan 20, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THIRTY-FOUR (34) NON-VENTED HIGH-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 24124952 ↗

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-3084-2024 · Aug 20, 2024 · Open, Classified
  Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
• 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-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-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-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-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-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.