EXACTAMIX EXACTA-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00085412586557), received between Aug 1, 2023 and Sep 23, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Emits Odor” (3 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Device Emits Odor

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875525 ↗
• MalfunctionApr 22, 2026Device Emits Odor

  IT WAS REPORTED THAT A EXACTAMIX PHARMACY COMPOUNDING DEVICE HAD A BURNING SMELL. THIS OCCURRED DURING PROGRAMMING/SETUP. THE EVENT OCCURRED IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24960602 ↗
• InjuryFeb 11, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED A NEONATAL PATIENT DEVELOPED HYPERMAGNESEMIA WHEN AN EXACTAMIX PHARMACY COMPOUNDING DEVICE DISPENSED MAGNESIUM WHEN IT WAS NOT PROGRAMMED. A NEONATE IN THE NEONATAL INTENSIVE CARE UNIT (NICU) WAS FOUND TO HAVE ¿AN EXTREMELY ELEVATED MAGNESIUM LEVEL¿ (ACTUAL MAGNESIUM LEVELS NOT REPORTED). THE ORDER IN THE HOSPITAL ELECTRONIC SYSTEM WAS ZERO FOR MAGNESIUM IN THE TOTAL PARENTERAL NUTRITION BAG; HOWEVER, THE LAB TESTING SHOWED THE MAGNESIUM LEVEL WAS 121.61 MG/DL. BASED ON THE TOTAL VOLUME OF 229.01, THE AMOUNT OF MAGNESIUM DISPENSED INTO THE BAG WAS 277.08MG OR 0.55ML. THE STAFF COMPARED THE VOLUME AND ANALYTES BETWEEN THE VALUES GENERATED DURING TESTING TO ALL OTHER BAGS PREPARED ON THE DATE OF THE EVENT. THEY ELIMINATED THE POSSIBILITY OF 2 LINES/PORTS BEING MIXED UP. ADDITIONALLY, THEY DID NOT IDENTIFY ANY OTHER ORDERS THAT MATCHED THE CALCULATED VOLUMES ASIDE FROM ONE DOSE THAT MATCHED THE 1.6ML WHICH WAS FOR AN ADULT ORDER. THE ADULT BAG WAS 980ML AND THE BAG OF THE PATIENT INVOLVED WAS 500ML. THE REPORTER HAS INSTRUCTED STAFF TO REMOVE THE MAGNESIUM FROM THE COMPOUNDER AND ADD IT MANUALLY. TREATMENT AND PATIENT OUTCOME WERE NOT REPORTED. NO FURTHER INFORMATION W

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24316949 ↗
• InjuryFeb 11, 2026Excess Flow or Over-Infusion

  IT WAS REPORTED A NEONATAL PATIENT DEVELOPED HYPERMAGNESEMIA WHEN AN EXACTAMIX PHARMACY COMPOUNDING DEVICE DISPENSED TOO MUCH MAGNESIUM. A NEONATE IN THE NEONATAL INTENSIVE CARE UNIT (NICU) WAS FOUND TO HAVE A MAGNESIUM LEVEL ¿2.5 TIMES¿ MORE THAN THE ACCEPTABLE LEVELS (ACTUAL MAGNESIUM LEVELS NOT REPORTED). THE ORDER IN THE HOSPITAL ELECTRONIC SYSTEM WAS 0.59ML TO BE ADDED TO THE TOTAL PARENTERAL NUTRITION BAG. THE LAB TESTED THE BAG FOUR TIMES WITH AN AVERAGE VALUE OF 179.44 MG/100ML. THE TOTAL VOLUME OF THE BAG WAS 445.36 ML. THE REPORTER STATED THAT APPROXIMATELY 1.6 ML OF MAGNESIUM WAS DISPENSED DURING PREPARATION BASED ON THEIR CALCULATION OF 799.15MG X 1ML/500MG = 1.598 ML. THE STAFF COMPARED THE VOLUME AND ANALYTES BETWEEN THE VALUES GENERATED DURING TESTING TO ALL OTHER BAGS PREPARED ON THE DATE OF THE EVENT. THEY ELIMINATED THE POSSIBILITY OF 2 LINES/PORTS BEING MIXED UP. ADDITIONALLY, THEY DID NOT IDENTIFY ANY OTHER ORDERS THAT MATCHED THE CALCULATED VOLUMES ASIDE FROM ONE DOSE THAT MATCHED THE 1.6ML WHICH WAS FOR AN ADULT ORDER. THE ADULT BAG WAS 980ML AND THE BAG OF THE PATIENT INVOLVED WAS 500ML. THE REPORTER HAS INSTRUCTED STAFF TO REMOVE THE MAGNESIUM FROM THE COMPO

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24316948 ↗
• MalfunctionJan 20, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE WIRES OF THE POWER CORD OF AN EM2400, MAIN MODULE WERE EXPOSED. THE ISSUE WAS NOTICED DURING SETUP. POWER CORD WAS SWAPPED WITH BACKUP TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24123236 ↗
• MalfunctionJul 29, 2025Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT AN EM2400, MAIN MODULE HAD A BURNING SMELL. THIS OCCURRED DURING TROUBLESHOOTING PROCESS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649626 ↗
• MalfunctionOct 31, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT ONE OF THE MAGNETS ON THE ROTOR DOOR OF AN EXACTAMIX COMPOUNDING DEVICE WAS MISSING. THE MISSING MAGNET ON THE ROTOR DOOR WAS DISCOVERED DURING PROGRAMMING/SETUP IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582002 ↗
• MalfunctionOct 31, 2024Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING AN EXACTAMIX PHARMACY COMPOUNDING DEVICE THE BAGS WERE CLOUDY. THIS WAS OBSERVED DURING DELIVERY IN A PHARMACY. TO RESOLVE THIS ISSUE, A VALVE SET AND A SECOND COMPOUNDER WERE SETUP WITH NO ISSUES NOTED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20580129 ↗
• MalfunctionSep 30, 2024Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING AN EXACTAMIX PHARMACY COMPOUNDING DEVICE THE BAGS WERE CLOUDY. THE CUSTOMER WAS TRYING RUN A ¿CLEAR¿ BAG BUT NOTICED THAT THE BAG LOOKED CLOUDY AFTER PUMPING AND THERE WERE LIPIDS ON PORT 1 AND 2. THIS ISSUE WAS RESOLVED AFTER CORRECTING THE CONFIGURATION AND RE-SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334177 ↗
• MalfunctionSep 23, 2024Precipitate in Device or Device Ingredient; Precipitate in Device or Device Ingredient

  IT WAS REPORTED THAT PRECIPITATE CONTAMINATION WAS OBSERVED ASSOCIATED WITH AN EXACTAMIX PHARMACY COMPOUNDING DEVICE. THE PRECIPITATE WAS OBSERVED BRIEFLY WHILE PRIMING AND VERIFYING. TO RESOLVE THIS ISSUE, RE-PRIMING WAS PERFORMED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20281191 ↗
• MalfunctionAug 1, 2023Break; Break

  IT WAS REPORTED THAT THE MAIN MODULE DOOR OF AN EXACTAMIX AUTOMATED COMPOUNDING DEVICE (ACD) WAS DAMAGED. THE DAMAGED DOOR WAS FURTHER DESCRIBED AS, ¿IN FAULT STATE / DOOR THAT HOUSES ROTOR AND TUBING WON'T CLOSE. IS UNHINGED¿. THIS ISSUE WAS OBSERVED DURING AN UNSPECIFIED PROCESS STEP PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17436554 ↗