Ethox 950194310Recalls & reported problems
Ethox Medical, LLC · ETHOX 4010H Infu-Surg, 1000ml Pressure Infuser Bag AP · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20889483151867), received between Oct 6, 2023 and Mar 5, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Infusion or Flow Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Electrolyte Imbalance1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Infusion or Flow Problem
IT WAS REPORTED THAT THE NURSE NOTICED THAT THE BLOOD PRESSURE CURVE DISPLAYED ON THE MONITOR WAS FLAT.
Patient problems: Electrolyte Imbalance
MAUDE report 24527661 ↗MalfunctionOct 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE USE OF THIS TYPE OF PRESSURE BAG IS NOT SUFFICIENTLY EFFECTIVE IN EMERGENCY SITUATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17890131 ↗
Other INFUSOR, PRESSURE, FOR I.V. BAGS devices
- Medex MX4705Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS36 reports
- InfuseIT ZIT-520Salter Labs · INFUSOR, PRESSURE, FOR I.V. BAGS19 reports
- Medex MX4810Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS15 reports
- Medline DYNJAAPI1000SMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS1 death9 reports
- Medex MX4805Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS9 reports
- Medline DYNJPI500CMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS7 reports
- Medline DYNJAAPI500SMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS6 reports
- Vital Signs IN800048Hygia Health Services, Inc. · Infusor, Pressure, For I.V. Bags3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.