Mask, Adult Aerosol, Vented 0250Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00709078003769), received between Oct 17, 2025 and Oct 29, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (8 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.

• MalfunctionOct 29, 2025Connection Problem; Connection Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 1314417-2025-00088 FOR THE FIRST REPORT. IT WAS REPORTED: THE MONOGHAN BREATH ACTUATED NEBULIZER (BAN) NEBULIZER THEY USED FOR MEDICATION DELIVERY FELL OFF OF THE ELBOW. THIS REPORTEDLY HAPPENED DURING PATIENT TREATMENT AND IT SPILLED THE MEDICATION WHICH DISRUPTED THERAPY. NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420473 ↗
• MalfunctionOct 29, 2025Connection Problem; Connection Problem

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 1314417-2025-00089 FOR THE SECOND REPORT. IT WAS REPORTED: THE MONOGHAN BREATH ACTUATED NEBULIZER (BAN) NEBULIZER THEY USED FOR MEDICATION DELIVERY FELL OFF OF THE ELBOW. THIS REPORTEDLY HAPPENED DURING PATIENT TREATMENT AND THEN FELL ON THE FLOOR NO PATIENT HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23420463 ↗
• MalfunctionOct 23, 2025Connection Problem; Connection Problem

  IT WAS REPORTED, THE ELBOW PIECE CAME OFF THE MASK AND DID NOT KEEP THE BREATH-ACTUATED NEBULIZER (BAN) NEBULIZER CONNECTED FOR MEDICATION DELIVERY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375634 ↗
• MalfunctionOct 17, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE FRONT OF THE PIECE OF THE MASK WHERE THE NEBULIZER CONNECTS TO CONTINUES TO FALL OFF WHEN GIVING BREATHING TREATMENTS TO PATIENTS. RESPIRATORY MANAGER STATED THAT SHE HAS SENT IN 5 COMPLAINTS TO HER SUPPLY CHAIN MANAGER REGARDING THIS ISSUE. THEY HAVE HAD ISSUES WITH MULTIPLE LOT NUMBERS. THIS SAMPLE IS A CURRENT LOT THAT THEY HAVE HAD ISSUES WITH. CURRENT ISSUE IS DISRUPTING WORKFLOW AS PROVIDERS ARE HAVING TO GO BACK AND FIX THE MASK, PUT THE NEBULIZER BACK IN, AND GET MORE MEDICATION DUE TO SPILLING. PLAN TO MEET WITH RESPIRATORY DIRECTOR AND BRING SAMPLES OF OTHER AEROSAL PRODUCTS. RESPIRATORY MANAGER SAID SHE WILL HAVE SAMPLES SET TO THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330971 ↗
• MalfunctionOct 17, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE FRONT OF THE PIECE OF THE MASK WHERE THE NEBULIZER CONNECTS TO CONTINUES TO FALL OFF WHEN GIVING BREATHING TREATMENTS TO PATIENTS. RESPIRATORY MANAGER STATED THAT SHE HAS SENT IN 5 COMPLAINTS TO HER SUPPLY CHAIN MANAGER REGARDING THIS ISSUE. THEY HAVE HAD ISSUES WITH MULTIPLE LOT NUMBERS. THIS SAMPLE IS A CURRENT LOT THAT THEY HAVE HAD ISSUES WITH. CURRENT ISSUE IS DISRUPTING WORKFLOW AS PROVIDERS ARE HAVING TO GO BACK AND FIX THE MASK, PUT THE NEBULIZER BACK IN, AND GET MORE MEDICATION DUE TO SPILLING. PLAN TO MEET WITH RESPIRATORY DIRECTOR AND BRING SAMPLES OF OTHER AEROSAL PRODUCTS. RESPIRATORY MANAGER SAID SHE WILL HAVE SAMPLES SET TO THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330970 ↗
• MalfunctionOct 17, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE FRONT OF THE PIECE OF THE MASK WHERE THE NEBULIZER CONNECTS TO CONTINUES TO FALL OFF WHEN GIVING BREATHING TREATMENTS TO PATIENTS. RESPIRATORY MANAGER STATED THAT SHE HAS SENT IN 5 COMPLAINTS TO HER SUPPLY CHAIN MANAGER REGARDING THIS ISSUE. THEY HAVE HAD ISSUES WITH MULTIPLE LOT NUMBERS. THIS SAMPLE IS A CURRENT LOT THAT THEY HAVE HAD ISSUES WITH. CURRENT ISSUE IS DISRUPTING WORKFLOW AS PROVIDERS ARE HAVING TO GO BACK AND FIX THE MASK, PUT THE NEBULIZER BACK IN, AND GET MORE MEDICATION DUE TO SPILLING. PLAN TO MEET WITH RESPIRATORY DIRECTOR AND BRING SAMPLES OF OTHER AEROSAL PRODUCTS. RESPIRATORY MANAGER SAID SHE WILL HAVE SAMPLES SET TO THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330969 ↗
• MalfunctionOct 17, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE FRONT OF THE PIECE OF THE MASK WHERE THE NEBULIZER CONNECTS TO CONTINUES TO FALL OFF WHEN GIVING BREATHING TREATMENTS TO PATIENTS. RESPIRATORY MANAGER STATED THAT SHE HAS SENT IN 5 COMPLAINTS TO HER SUPPLY CHAIN MANAGER REGARDING THIS ISSUE. THEY HAVE HAD ISSUES WITH MULTIPLE LOT NUMBERS. THIS SAMPLE IS A CURRENT LOT THAT THEY HAVE HAD ISSUES WITH. CURRENT ISSUE IS DISRUPTING WORKFLOW AS PROVIDERS ARE HAVING TO GO BACK AND FIX THE MASK, PUT THE NEBULIZER BACK IN, AND GET MORE MEDICATION DUE TO SPILLING. PLAN TO MEET WITH RESPIRATORY DIRECTOR AND BRING SAMPLES OF OTHER AEROSAL PRODUCTS. RESPIRATORY MANAGER SAID SHE WILL HAVE SAMPLES SET TO THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330968 ↗
• MalfunctionOct 17, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE FRONT OF THE PIECE OF THE MASK WHERE THE NEBULIZER CONNECTS TO CONTINUES TO FALL OFF WHEN GIVING BREATHING TREATMENTS TO PATIENTS. RESPIRATORY MANAGER STATED THAT SHE HAS SENT IN 5 COMPLAINTS TO HER SUPPLY CHAIN MANAGER REGARDING THIS ISSUE. THEY HAVE HAD ISSUES WITH MULTIPLE LOT NUMBERS. THIS SAMPLE IS A CURRENT LOT THAT THEY HAVE HAD ISSUES WITH. CURRENT ISSUE IS DISRUPTING WORKFLOW AS PROVIDERS ARE HAVING TO GO BACK AND FIX THE MASK, PUT THE NEBULIZER BACK IN, AND GET MORE MEDICATION DUE TO SPILLING. PLAN TO MEET WITH RESPIRATORY DIRECTOR AND BRING SAMPLES OF OTHER AEROSAL PRODUCTS. RESPIRATORY MANAGER SAID SHE WILL HAVE SAMPLES SET TO THE SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23324060 ↗