Salter AIRE Elite 8350-8900Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00607411001451), received between Sep 11, 2025 and May 6, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (2 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.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Output Problem

  IT WAS REPORTED THAT A SALTER AIRE ELITE COMPRESSOR WAS NOT PRODUCING MIST AS INTENDED DURING PATIENT ATTEMPTS TO USE THE DEVICE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25107678 ↗
• MalfunctionApr 3, 2026Intermittent Loss of Power

  IT WAS REPORTED THAT THE ON/OFF SWITCH ON THE SALTER AIRE ELITE COMPRESSOR NEBULIZER DOES NOT STAY IN THE SELECTED POSITION. THE SWITCH INTERMITTENTLY CAUSES THE UNIT TO CYCLE BETWEEN RUNNING AND NOT RUNNING WITHOUT ANY USER INTERACTION. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778087 ↗
• MalfunctionFeb 13, 2026Output Problem

  IT WAS REPORTED THAT THE UNIT WILL NOT DELIVER MEDICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24340037 ↗
• MalfunctionNov 21, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE NEBULIZER TUBING DISCONNECTED, RESULTING IN THE PATIENT NOT RECEIVING THE MAXIMUM TREATMENT. THERE WAS NO INDICATION OF A DELAY IN THERAPY OR ANY HARM OR INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23623898 ↗
• MalfunctionOct 15, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED, THE NEBULIZER WOULD NOT POWER ON; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306109 ↗
• MalfunctionOct 2, 2025Failure to Power Up; Failure to Power Up

  IT WAS REPORTED, THE NEBULIZER WOULD NOT TURN ON, DURING PATIENT USE. THE DEVICE WAS REPLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23205946 ↗
• MalfunctionSep 11, 2025Infusion or Flow Problem; Infusion or Flow Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2025-00059 FOR THE FIRST REPORT. IT WAS REPORTED: THE REPLACEMENT NEBULIZER CUP DID NOT AEROSOLIZE THE MEDICATIONS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031350 ↗
• MalfunctionSep 11, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2025-00060 FOR THE SECOND REPORT. IT WAS REPORTED: THE DEVICE WOULD NOT AEROSOLIZE THE MEDICATIONS; THE NEBULIZER CUP WAS REPLACED; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031349 ↗