EXACTAMIX H938176Recalls & reported problems
Baxter Healthcare Corporation · EXACTAMIX Inlet, Syringe Inlet · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Exactamix syringe inlet has 229 adverse event reports, all malfunctions, with no injuries and no deaths. The reports mostly describe particles found on inlets or inside their packaging before use, with no patient involvement. Of its 2 recalls, 1 is open; it began in August 2024 over particulate matter in the inlets, while the other is closed. Reports fell from 107 in the previous 12 months to 35 in the most recent 12 months.
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
- 232
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 232 adverse event reports that list this exact device (DI 00085412475813), received between Mar 12, 2018 and Sep 9, 2026 — classified as 232 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (217 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-3085-2024 · 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-1911-2018 · Root cause: Labeling Change Control · FDA record ↗
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material217
- Contamination6
- Unsealed Device Packaging4
- Delivered as Unsterile Product2
- Fluid/Blood Leak1
- Packaging Problem1
- Partial Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions220
- No Patient Involvement12
Recent adverse event reports
The 25 most recent of 232 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 50696051 ↗MalfunctionSep 9, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50696050 ↗MalfunctionSep 2, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573736 ↗MalfunctionSep 2, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568795 ↗MalfunctionJun 25, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SIXTY EIGHT (68) SYRINGE INLETS, MICRO-VOLUME WITH LUER LOCK END 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 25630611 ↗MalfunctionJun 22, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS IDENTIFIED IN A EXACTAMIX SYRINGE INLET (CONNECTOR). THE ISSUE WAS IDENTIFIED AT THE PHARMACY PRIOR COMPOUNDING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25586062 ↗MalfunctionMay 21, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PARTICULATE MATTER (PM) WAS OBSERVED IN AN EXACTAMIX INLET, SYRINGE INLET. THE ISSUE WAS DESCRIBED AS "A YELLOW STAIN ON THE WHITE PART OF THE DEVICE PACKAGING". THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240910 ↗MalfunctionMay 8, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PARTICULATE MATTER WAS FOUND ON THE INLETS INSIDE THE PACKAGING OF THIRTEEN (13) EXACTAMIX SYRINGE INLETS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129346 ↗MalfunctionMay 8, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PARTICULATE MATTER WAS FOUND ON THE INLETS INSIDE THE PACKAGING OF SEVENTEEN (17) EXACTAMIX SYRINGE INLETS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128936 ↗MalfunctionApr 17, 2026Contamination
IT WAS REPORTED THAT NINETEEN (19) 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 24915939 ↗MalfunctionApr 15, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FIFTY THREE (53) SYRINGE 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 24891224 ↗MalfunctionMar 23, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN EXACTAMIX SYRINGE INLET HAD FOREIGN MATTER IN AN UNSPECIFIED LOCATION. THIS WAS OBSERVED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24671212 ↗MalfunctionMar 5, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN EXACTAMIX SYRINGE INLET HAD PARTICULATE MATTER (PM) IN THE DEVICE. THE PM WAS DESCRIBED AS, ¿HAIR/PLASTIC STRIPE¿. 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 24524705 ↗MalfunctionMar 3, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A MICRO-VOLUME WITH LUER LOCK END SYRINGE INLET HAD A BLACK DOT VISIBLE IN THE HOSE. 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 24503203 ↗MalfunctionMar 3, 2026Unsealed Device Packaging
IT WAS REPORTED THAT THE PACKAGING OF AN EXACTAMIX SYRINGE INLET WAS DAMAGED (OPENED). 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 24503118 ↗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 SYRINGE 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 24457207 ↗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 SYRINGE 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 24456955 ↗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 SYRINGE 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 24456908 ↗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 SYRINGE 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 24456630 ↗MalfunctionJan 20, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOURTEEN (14) MICRO-VOLUME WITH LUER LOCK END SYRINGE 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 24125501 ↗MalfunctionJan 20, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT NINETEEN (19) MICRO-VOLUME WITH LUER LOCK END SYRINGE 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 24125399 ↗MalfunctionJan 17, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOUR (4) SYRINGE INLETS 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 24105235 ↗MalfunctionJan 6, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED EIGHT EXACTAMIX INLETS HAD ¿MOVABLE AND IMMOVABLE BLACK PARTICLES INSIDE THE PACKAGING.¿ THE PARTICULATE WAS OBSERVED PRIOR TO PATIENT USE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23985854 ↗MalfunctionJan 2, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT NINETEEN (19) SYRINGE INLETS, MICRO-VOLUME WITH LUER LOCK END HAD PARTICULATE MATTER. THIS WAS NOTICED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944802 ↗MalfunctionJan 2, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SEVENTEEN (17) SYRINGE INLETS, MICRO-VOLUME WITH LUER LOCK END HAD PARTICULATE MATTER. THIS WAS NOTICED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944800 ↗
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-3082-2024 · Aug 20, 2024 · Open, ClassifiedBaxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device
- Z-3083-2024 · Aug 20, 2024 · Open, ClassifiedBaxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, 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-1909-2018 · Apr 25, 2018 · TerminatedBaxter 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 · 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-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-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 Set, i.V. Fluid transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- Alaris, SmartSite 20027EBD Switzerland Sàrl · Set, i.V. Fluid transfer1 death183 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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