WarmAir® 135Recalls & reported problems
Gentherm Medical, LLC · Convective Warming System · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10613031861860), received between Jul 29, 2025 and Feb 19, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical Overstress” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical Overstress1
- Failure to Power Up1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 19, 2026Electrical Overstress
THE CUSTOMER HAS ALLEGED THE CPU BOARD IS "BURNED".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24386941 ↗MalfunctionJul 29, 2025Failure to Power Up; Failure to Power Up
CUSTOMER REPORTS: THIS WARM AIR 135 IS NOT TURNING ON, AND WHEN THE CUSTOMER OPENED THE UNIT THEY FOUND SOME DISCOLORATION ON THE FUSE IN THE POWER BOARD. NOTE: THE DEVICE AGE IS BEYOND ITS USEFUL LIFE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22643744 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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