Salter AIRE Elite SO-1774BERecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607411918346), received between Nov 12, 2025 and Mar 18, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K870027); 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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Energy Output Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 3004748541-2026-00051 FOR THE SECOND REPORT. REFER TO 3004748541-2026-00052 FOR THE THIRD REPORT. REFER TO 3004748541-2026-00053 FOR THE FOURTH REPORT. REFER TO 3004748541-2026-00054 FOR THE FIFTH REPORT. IT WAS REPORTED, THE AT HOME ASTHMA USER HAS USED THE SALTER AIRE ELITE COMPRESSOR APPROXIMATELY FIVE TIMES, AND EACH TIME THEY TURNED IT ON, THE MOTOR STARTED OUT REGULAR BUT WOULD IMMEDIATELY SLOW DOWN TO WHERE THERE WAS NO MEDICINE COMING OUT. THEY HAD TO TURN IT ON AND OFF ABOUT 15 TIMES BEFORE IT WORKED AT REGULAR SPEED. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635498 ↗
• MalfunctionMar 18, 2026Energy Output Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 3004748541-2026-00050 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00051 FOR THE SECOND REPORT. REFER TO 3004748541-2026-00052 FOR THE THIRD REPORT . REFER TO 3004748541-2026-00054 FOR THE FIFTH REPORT. IT WAS REPORTED, THE AT HOME ASTHMA USER HAS USED THE SALTER AIRE ELITE COMPRESSOR APPROXIMATELY FIVE TIMES, AND EACH TIME THEY TURNED IT ON, THE MOTOR STARTED OUT REGULAR BUT WOULD IMMEDIATELY SLOW DOWN TO WHERE THERE WAS NO MEDICINE COMING OUT. THEY HAD TO TURN IT ON AND OFF ABOUT 15 TIMES BEFORE IT WORKED AT REGULAR SPEED. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634141 ↗
• MalfunctionMar 18, 2026Energy Output Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 3004748541-2026-00050 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00052 FOR THE THIRD REPORT. REFER TO 3004748541-2026-00053 FOR THE FOURTH REPORT. REFER TO 3004748541-2026-00054 FOR THE FIFTH REPORT. IT WAS REPORTED, THE AT HOME ASTHMA USER HAS USED THE SALTER AIRE ELITE COMPRESSOR APPROXIMATELY FIVE TIMES, AND EACH TIME THEY TURNED IT ON, THE MOTOR STARTED OUT REGULAR BUT WOULD IMMEDIATELY SLOW DOWN TO WHERE THERE WAS NO MEDICINE COMING OUT. THEY HAD TO TURN IT ON AND OFF ABOUT 15 TIMES BEFORE IT WORKED AT REGULAR SPEED. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634140 ↗
• MalfunctionMar 18, 2026Energy Output Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 3004748541-2026-00050 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00051 FOR THE SECOND REPORT. REFER TO 3004748541-2026-00053 FOR THE FOURTH REPORT . REFER TO 3004748541-2026-00054 FOR THE FIFTH REPORT. IT WAS REPORTED, THE AT HOME ASTHMA USER HAS USED THE SALTER AIRE ELITE COMPRESSOR APPROXIMATELY FIVE TIMES, AND EACH TIME THEY TURNED IT ON, THE MOTOR STARTED OUT REGULAR BUT WOULD IMMEDIATELY SLOW DOWN TO WHERE THERE WAS NO MEDICINE COMING OUT. THEY HAD TO TURN IT ON AND OFF ABOUT 15 TIMES BEFORE IT WORKED AT REGULAR SPEED. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634139 ↗
• MalfunctionMar 18, 2026Energy Output Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH THE SAME UNIT, INVOLVING THE SAME PATIENT. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 3004748541-2026-00050 FOR THE FIRST REPORT. REFER TO 3004748541-2026-00051 FOR THE SECOND REPORT. REFER TO 3004748541-2026-00052 FOR THE THIRD REPORT. REFER TO 3004748541-2026-00053 FOR THE FOURTH REPORT. IT WAS REPORTED, THE AT HOME ASTHMA USER HAS USED THE SALTER AIRE ELITE COMPRESSOR APPROXIMATELY FIVE TIMES, AND EACH TIME THEY TURNED IT ON, THE MOTOR STARTED OUT REGULAR BUT WOULD IMMEDIATELY SLOW DOWN TO WHERE THERE WAS NO MEDICINE COMING OUT. THEY HAD TO TURN IT ON AND OFF ABOUT 15 TIMES BEFORE IT WORKED AT REGULAR SPEED. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634138 ↗
• MalfunctionNov 21, 2025No Pressure; No Pressure

  IT WAS REPORTED: THE UNIT WAS NOT PUTTING OUT ANY PRESSURE. DETECTED DURING USE. THE PATIENT WAS NOT IMPACTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23618531 ↗
• MalfunctionNov 12, 2025Output Problem; Output Problem

  NEBULIZER LOW FLOW WAS REPORTED; THERE WAS NO REPORT OF A DELAY IN THERAPY AND/OR HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539266 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K870027. One submission often covers many models, so check the product and lot details in each record.

• Z-0108-2012 · Mar 25, 2011 · Terminated
  Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.