EXACTAMIX H9382400-MRRecalls & reported problems
Baxter Healthcare Corporation · EXACTAMIX Compounder, Main Module Refurbished Unit · Class 2
All models of EXACTAMIX (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412482644), received between Dec 1, 2025 and Dec 1, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Break; Break
IT WAS REPORTED THAT AN EM 2400, MAIN MODULE HAD A DAMAGED POWER CORD. 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 23687627 ↗
Other SYSTEM/DEVICE, PHARMACY COMPOUNDING devices
- EXACTAMIX H938175Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING3 recalls263 reports
- EXACTAMIX H938174Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING2 recalls238 reports
- B.BRAUN 2112550B. Braun Medical Inc. · SYSTEM/DEVICE, PHARMACY COMPOUNDING74 reports
- ABACUS 83003393Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING1 recall0 reports
- IVX StationOmnicell, Inc. · System/Device, Pharmacy Compounding1 recall0 reports
- ABACUS 83003392Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING1 recall0 reports
- EXACTAMIX EXM24DYBaxter Healthcare Corporation · System/device, pharmacy compounding1 recall0 reports
- ABACUS 83003391Baxter Healthcare Corporation · SYSTEM/DEVICE, PHARMACY COMPOUNDING1 recall0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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