HUDSON RCI HUD05014Recalls & reported problems
Medline Industries, Inc. · AQUATHERM III HEATER,ADJUST,LVN · Class 2
All models of HUDSON RCI (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10197344011629), received between Apr 30, 2026 and Sep 30, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Insufficient Heating” (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. 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
- Insufficient Heating3
- Crack1
- Damaged Thread1
- Failure to Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Power Up
It was reported that the unit will not power on.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949823 ↗MalfunctionSep 29, 2026Damaged Thread
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935147 ↗MalfunctionJun 10, 2026Insufficient Heating
PER REPORT, "CUSTOMER CALLED IN STATING THE ITEMS IS NOT HEATING UP." DUE DILIGENCE HAS BEEN COMPLETED. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25460651 ↗MalfunctionMay 13, 2026Insufficient Heating
IT WAS REPORTED THAT "WATER IS NOT RUNNING THROUGH THE HEATER AND IT IS NOT HEATING UP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25162194 ↗MalfunctionApr 30, 2026Insufficient Heating
PER REPORT, "PAM HEALTH SPECIALITY HOSPITAL HEALTH OF DENVER PURCHASED UNITS. CUSTOMER REPORTS 2 UNITS NOT HEATING UP AND ONE HAS CRACK IN CASING AW8269."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25046381 ↗MalfunctionApr 30, 2026Crack
PER REPORT, "(B)(6) PURCHASED UNITS. CUSTOMER REPORTS 2 UNITS NOT HEATING UP AND ONE HAS CRACK IN CASING AW8269."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25046380 ↗
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- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 reports
- Portex Z110-14Icu Medical, Inc. · NEBULIZER (DIRECT PATIENT INTERFACE)5 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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