EXACTAMIX H9382400-MRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00085412482637), received between Apr 21, 2020 and Sep 9, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Device Emits Odor

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698597 ↗
• MalfunctionJun 12, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MAGNETIC DOOR LATCH DETACHED FROM AN EXACTAMIX COMPOUNDER. THE EVENT OCCURRED IN THE PHARMACY DEPARTMENT DURING DEVICE SET UP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25491942 ↗
• MalfunctionMar 31, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE POWER CORD OF AN EM 2400, MAIN MODULE WAS EXPOSED. THE ISSUE WAS OBSERVED IN THE PHARMACY. THE POWER CORD WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747060 ↗
• MalfunctionJan 14, 2026Difficult to Open or Close

  IT WAS REPORTED THAT THE GREEN DOOR OF AN EM 2400, MAIN MODULE DID NOT CLOSE PROPERLY. THE ISSUE WAS DESCRIBED AS THE GREEN DOOR FAILED TO CLOSE PROPERLY, AND THEY PLACED A VIAL ON TOP TO HOLD IT DOWN AS A TEMPORARY SOLUTION. THIS OCCURRED IN THE PHARMACY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24067858 ↗
• MalfunctionDec 5, 2025Break; Break

  DURING EVALUATION OF A RETURNED EXACTAMIX 2400 COMPOUNDER, IT WAS OBSERVED THAT THERE WERE REVERSED MAGNETS ON THE PUMP DOOR WHICH RESULTED IN FAILED RESULTS DURING FUNCTIONAL SYSTEM LEVEL TESTING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23735443 ↗
• MalfunctionNov 25, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE POWER CORD OF AN EXACTAMIX 2400 MAIN MODULE WAS TORN. 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 23652150 ↗
• MalfunctionMay 12, 2025Break; Break

  IT WAS REPORTED THAT THE GREEN DOOR OF AN EM 2400, MAIN MODULE COULD NOT BE CLOSED AND THE DOOR COULD NOT BE REPLACED BECAUSE THE BACKUP PUMP SCREW WAS STRIPPED. THIS ISSUE WAS OBSERVED DURING PROGRAMMING/SETUP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22005663 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT RECEIVED TOTAL PARENTERAL NUTRITION (TPN) COMPOUNDED BY AN AUTOMATED COMPOUNDING DEVICE EM 2400 MAIN MODULE COMPOUNDER. AFTER ADMINISTRATION OF THE TPN, THE PATIENT EXPERIENCED HIGHER THAN EXPECTED BLOOD GLUCOSE LEVELS. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS "105 IN THE MORNING", A "BAG WAS HUNG" AT 18:00 HOURS AND THE PATIENT'S BLOOD GLUCOSE LEVEL WAS FOUND TO BE 282 AT 21:42 HRS. IT WAS FURTHER REPORTED THAT "THE PROVIDERS OPTED TO RUN A BAG OF D10/0.45NS ON THE COMPOUNDER AND GIVE IT TO THE PATIENT". ACCORDING TO THE REPORTER, THE PATIENT'S BLOOD GLUCOSE STARTED TO ¿TREND BACK DOWN¿. THE PATIENT WAS ALSO INITIATED ON ¿CLAF/VANC¿ ANTIBIOTICS "TO COVER FOR POTENTIAL INFECTION". NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 16437293 ↗
• MalfunctionFeb 17, 2023Break; Break

  IT WAS REPORTED UNSPECIFIED DAMAGE WAS OBSERVED TO THE ROTOR DOOR ON AN EM 2400, MAIN MODULE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16400814 ↗
• MalfunctionDec 13, 2022Break; Break

  IT WAS REPORTED THAT A EM 2400, MAIN MODULE DOOR WAS DAMAGED. ADDITIONALLY, THE "MACHINE CRASHES" WHEN A PRODUCT IS ADDED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15965600 ↗
• MalfunctionApr 20, 2022Break; Break

  IT WAS REPORTED THAT THE GREEN DOOR OF A EM 2400, MAIN MODULE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159935 ↗
• MalfunctionAug 6, 2021Break; Break

  IT WAS REPORTED THAT THE GREEN DOOR OF AN EXACTAMIX AUTOMATED COMPOUNDING DEVICE WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12291340 ↗
• MalfunctionDec 29, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT THE GREEN PUMP DOOR OF AN EXACTAMIX AUTOMATED COMPOUNDING DEVICE HAS MISSING PARTS. IT WAS FURTHER REPORTED THE GREEN DOOR HAD MISSING SCREWS. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 11089748 ↗
• MalfunctionJun 9, 2020Break; Break

  IT WAS REPORTED THAT AN EM2400 MAIN MODULE HAD A BROKEN GREEN DOOR. THIS WAS FURTHER DESCRIBED BY THE CUSTOMER AS ¿LID WAS SNAPPED IN HALF¿. THIS WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10134819 ↗
• MalfunctionApr 21, 2020Break; Break

  IT WAS REPORTED THAT AN EM2400 MAIN COMPOUNDER MODULE HAD STRIPPED SCREWS ON THE GREEN (PUMP) DOOR. THIS WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9982881 ↗