EXACTAMIX H938174Recalls & reported problems
Baxter Healthcare Corporation · EXACTAMIX Inlet, Vented, High-Volume Inlet · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Baxter Exactamix vented inlet is a disposable part used in pharmacy compounding. The 237 reports mostly describe particles, lint, hair or blood-like spots found on the inlets or their packaging, and some describe fluid leaks, though several state no patient was involved. The reports include no injuries and no deaths, and reports fell to 40 in the last 12 months from 91 in the 12 months before. There are 2 recalls, one open over particles found in the disposable inlets and one closed over labels that extended expiration dates.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 238
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 238 adverse event reports that list this exact device (DI 00085412475790), received between Jan 30, 2019 and Sep 28, 2026 — classified as 238 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (196 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.
Reports received per month
Recalls naming this device
- 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 · FDA record ↗
- 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 · FDA record ↗
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material196
- Fluid/Blood Leak20
- Contamination11
- Air/Gas in Device9
- Disconnection6
- Material Puncture/Hole4
- Unsealed Device Packaging3
- Loose or Intermittent Connection2
Patient problems
- No Clinical Signs, Symptoms or Conditions221
- No Patient Involvement17
Recent adverse event reports
The 25 most recent of 238 reports, 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 11, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50740050 ↗MalfunctionSep 3, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595878 ↗MalfunctionAug 28, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508268 ↗MalfunctionAug 13, 2026Device Contamination with Chemical or Other Material; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237019 ↗MalfunctionAug 13, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236746 ↗MalfunctionAug 13, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236745 ↗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 OF THIRTY ONE (31) VENTED HIGH 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 25298912 ↗MalfunctionApr 16, 2026Contamination
IT WAS REPORTED THAT PARTICULATE MATTER WAS OBSERVED IN THE OUTER PACKAGING, INLET, OR CONNECTORS OF EIGHT (8) EXACTAMIX INLETS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24905246 ↗MalfunctionApr 16, 2026Contamination
IT WAS REPORTED THAT PARTICULATE MATTER WAS OBSERVED IN THE OUTER PACKAGING, INLET, OR CONNECTORS OF THREE (3) EXACTAMIX INLETS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899822 ↗MalfunctionApr 16, 2026Contamination
IT WAS REPORTED THAT PARTICULATE MATTER WAS OBSERVED IN THE OUTER PACKAGING, INLET, OR CONNECTORS OF AN EXACTAMIX INLET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24899530 ↗MalfunctionApr 2, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A BLACK HAIR WAS FOUND INSIDE THE INNER PACKAGING OF A VENTED HIGH-VOLUME INLET. 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 24769431 ↗MalfunctionMar 12, 2026Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS REPORTED THAT TWO (2) EXACTAMIX VENTED, HIGH-VOLUME INLETS HAD LEAKED DUE TO THE WHITE INLET CLIP (SLIP CONNECTOR) DISCONNECTING FROM THE CLEAR INLET TUBING. THIS WAS OBSERVED DURING COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24582369 ↗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, 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 24460851 ↗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, 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 24460780 ↗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, 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 24459514 ↗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 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 24436566 ↗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 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 24436182 ↗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 AN EXACTAMIX VENTED, HIGH-VOLUME INLET. 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 24431568 ↗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 THREE (3) VENTED, HIGH-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 24429801 ↗MalfunctionJan 30, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SEVENTEEN (17) VENTED HIGH-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 24226572 ↗MalfunctionJan 30, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THREE (3) VENTED HIGH-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 24226569 ↗MalfunctionJan 17, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN VENTED HIGH-VOLUME INLET HAD FOREIGN MATTER IN AN UNSPECIFIED LOCATION. THE ISSUE WAS NOTICED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24105231 ↗MalfunctionJan 16, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN UNSPECIFIED UNITS OF VENTED HIGH-VOLUME INLETS HAD PARTICLES. THE PARTICLES WERE IDENTIFIED AS PUNCHED OUT PIECES OF RUBBER STOPPER MATERIAL FROM MEDICATION BOTTLES WITH A ¿UK PORT¿ (19¿24). 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 24104369 ↗MalfunctionJan 12, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER CONTAMINATION IN TWENTY ONE (21) EXACTAMIX VENTED, HIGH-VOLUME INLETS. THE PM WAS DESCRIBED AS ¿HAIRS, PARTICLES, AND LINT IN THE OUTER PACKAGING, THE INLET, AND/OR ON THE CONNECTORS¿. THESE ISSUES WERE OBSERVED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24048058 ↗
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, ClassifiedBrand 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, ClassifiedBaxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device
- Z-3085-2024 · Aug 20, 2024 · Open, ClassifiedBaxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device
- Z-3082-2024 · Aug 20, 2024 · Open, ClassifiedBaxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
- Z-1002-2024 · Dec 22, 2023 · Open, ClassifiedBaxter Exactamix Pro 2400, REF EXM24DY
- Z-1001-2024 · Dec 22, 2023 · Open, ClassifiedBaxter Exactamix Pro 1200, REF EXM12DY
- Z-1570-2022 · Jul 14, 2022 · Open, ClassifiedThe 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 · TerminatedBaxter 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 · TerminatedBaxter 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-1910-2018 · Apr 25, 2018 · TerminatedBaxter 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-1752-2013 · Jun 4, 2013 · TerminatedExactaMix 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 · TerminatedExacta-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 · TerminatedExacta-Mix 2400 pharmacy compounding system.
Other SYSTEM/DEVICE, PHARMACY COMPOUNDING devices
- EXACTAMIX H938175Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING3 recalls263 reports
- B.BRAUN 2112550B. Braun Medical Inc. · SYSTEM/DEVICE, PHARMACY COMPOUNDING74 reports
- EXACTAMIX EXM12DYBaxter Healthcare Corporation · System/device, pharmacy compounding1 recall0 reports
- ABACUS 83003393Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING1 recall0 reports
- ABACUS 83003391Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING1 recall0 reports
- ABACUS 83003392Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING1 recall0 reports
- IVX StationOmnicell, Inc. · System/Device, Pharmacy Compounding1 recall0 reports
- EXACTAMIX EXM24DYBaxter Healthcare Corporation · System/device, pharmacy compounding1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.