Level 1 EQ-5000Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 50695085850005), received between May 13, 2021 and Nov 13, 2025 — classified as 5 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (12 reports).

1 other recall cover devices cleared under the same FDA submission (K011907); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Loss of Power; Loss of Power

  IT WAS REPORTED THAT THE POWER SUPPLY CUT OFF MIDWAY AND FAILED TO TURN ON AFTERWARD. THIS OCCURRED DURING INFUSION AT THE FACILITY. THERE WAS A PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546854 ↗
• MalfunctionAug 14, 2025Material Fragmentation; Power Problem; Material Fragmentation; Power Problem

  IT WAS REPORTED THAT THE POWER SUPPLY WAS UNSTABLE, INTERMITTENTLY TURNING ON AND OFF DURING OPERATION. THIS OCCURRED DURING PRIMING AT THE FACILITY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811134 ↗
• MalfunctionJul 22, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE CONNECTOR IS BROKEN AND SOMETIMES, AIR DOES NOT BLOW OUT. THE EVENT OCCURRED BEFORE PATIENT USE AT THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22569536 ↗
• MalfunctionJul 14, 2025Temperature Problem; Excessive Heating; Temperature Problem; Excessive Heating

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A HIGH TEMPERATURE. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496138 ↗
• MalfunctionApr 29, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT A LOW TEMPERATURE ALARM OCCURRED. THIS OCCURRED DURING INFUSION AT THE FACILITY. THERE WAS A PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926355 ↗
• MalfunctionApr 7, 2025Insufficient Heating; Temperature Problem; Insufficient Heating; Temperature Problem

  IT WAS REPORTED THAT THE TEMPERATURE DID NOT RISE. EVENT OCCURRED BEFORE PATIENT USE/DURING TESTING AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARMED REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21788563 ↗
• MalfunctionMar 31, 2025Leak/Splash; Electrical Power Problem; Leak/Splash; Electrical Power Problem

  IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRIC LEAKAGE. THIS OCCURRED DURING INFUSION AT THE FACILITY. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734293 ↗
• MalfunctionMar 26, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE SENSOR HAS A FALSE CONTACT, SO THE GENERATOR DOES NOT HEAT UP THE AIR. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698480 ↗
• MalfunctionMar 18, 2025Electrical /Electronic Property Problem; Device Emits Odor; Electrical /Electronic Property Problem; Device Emits Odor

  IT WAS REPORTED THAT THE POWER DOES NOT TURN ON. THERE'S A STRANGE SMELL. EVENT OCCURRED BEFORE PATIENT USE/DURING PRIMING AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARMED REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631527 ↗
• MalfunctionFeb 19, 2025Erratic or Intermittent Display; Ambient Temperature Problem; Erratic or Intermittent Display; Ambient Temperature Problem

  IT WAS REPORTED THAT EVEN WHEN THE POWER WAS TURNED ON, THE AIR WAS NOT BLOWING, AND VARIOUS NUMBERS WERE SEEN ON THE TEMPERATURE DISPLAY. THERE WERE NO PATIENT HARM AND/OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417090 ↗
• InjuryFeb 13, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT PATIENT COMPLAINED EXPERIENCING OVERHEATING AFTER BEING COVERED WITH A FULL BODY BLANKET. AFTER THE HEATER WAS STOPPED, THE HOSE APPEARED TO BE MUCH HOTTER THAN USUAL, EVEN THOUGH THE DIAL SHOWED 25° AND THE SETPOINT WAS 44°. THE PATIENT PRESENTED REDNESS ON BOTH LEGS AND COMPLAINED OF PAIN NEAR HER RIGHT ANKLE. AFTER THE INCIDENT, THE PATIENT WAS REFERRED TO A DERMATOLOGIST AND A PLASTIC SURGERY SPECIALIST FOR WITH FURTHER TREATMENT AND BANDAGING.

  Patient problems: Burn(s); Skin Burning Sensation

  MAUDE report 21379763 ↗
• MalfunctionFeb 12, 2025Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE DEVICE TEMPERATURE WAS NOT RISING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21368871 ↗
• MalfunctionFeb 11, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE TEMPERATURE WAS NOT RISING. THERE WERE PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357359 ↗
• MalfunctionFeb 11, 2025Temperature Problem; Temperature Problem

  IT WAS STATED IN THE REPORT THAT THE TEMPERATURE WAS UNSTABLE. EVENT OCCURRED DURING PATIENT USE AT THE FACILITY. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21357279 ↗
• MalfunctionJan 24, 2025Circuit Failure; Overheating of Device; Unexpected Shutdown; Excessive Heating; Circuit Failure; Overheating of Device; Unexpected Shutdown; Excessive Heating

  IT WAS REPORTED THAT THE WARMER WAS STOPPING AND THAT THE OVER-TEMPERATURE AND THE MAINTENANCE INDICATORS WERE RAPIDLY BLINKING. THE DEVICE WAS BEING USED ON A PATIENT WHILE THIS HAPPENED. NO PATIENT HARM OR MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21229499 ↗
• MalfunctionJan 15, 2025Break; Insufficient Heating; No Device Output; Break; Insufficient Heating; No Device Output

  IT WAS REPORTED THAT "THE TEMPERATURE WON'T RISE, THE EQUIPMENT WON'T WORK, AND THE HOSE IS BROKEN". THERE WAS NO PATIENT INVOLVEMENT AND REPORTER CONFIRMED THAT THERE WERE NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162256 ↗
• MalfunctionJan 14, 2025Insufficient Heating; Key or Button Unresponsive/not Working; Insufficient Heating; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE PRODUCT DID NOT PRODUCE WARM AIR. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152674 ↗
• MalfunctionJan 10, 2025Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT THE TEMPERATURE DOESN'T RISE. EVENT OCCURRED BEFORE PATIENT USE, DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARMED REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21132300 ↗
• MalfunctionDec 31, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE INDICATOR WAS FLASHING. THE FAULT OCCURRED WHILE IN USE WITH THE PATIENT. THERE WAS KNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047665 ↗
• MalfunctionDec 26, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE STOPPED WORKING WHILE IN PATIENT USE. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21021049 ↗
• MalfunctionNov 11, 2024Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THE TEMPERATURE DID NOT REACH THE SET VALUE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652331 ↗
• MalfunctionNov 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING THE TEMPERATURE OF THE WARMER, INCORRECT READINGS WERE RECEIVED. IN ONE INSTANCE, WHEN SETTING THE TEMPERATURE TO 36 DEGREES CELSIUS, THE DEVICE SHOWED A RECORDING OF 12 DEGREES CELSIUS. THERE WAS UNKNOWN PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20609855 ↗
• MalfunctionOct 28, 2024Device Alarm System; Erratic or Intermittent Display; Device Alarm System; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE TEMPERATURE SHOWS ABNORMAL DISPLAY AND AN ALARM SOUNDS. EVENT OCCURRED WHILE PATIENT USE, DURING PATIENT ADMINISTRATION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20546735 ↗
• MalfunctionOct 21, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THERE WAS A POOR CONNECTION ALARM THAT RANG. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARMED REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495568 ↗
• MalfunctionOct 21, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DISCONNECT INDICATOR ALARM SOUNDS. THERE WAS KNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494599 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K011907. One submission often covers many models, so check the product and lot details in each record.

• Z-0497-05 · Dec 15, 2004 · Terminated
  Equator Forced Air Convective Warming System, Reference Number EQ 5000