N/A 8904-7Recalls & reported problems

Salter Labs · Salter Labs™ Nebulizer (Adult) with aerosol mask, 7’ (2.1 m) supply tube, over-the-ear fixation · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607411102028), received between Aug 21, 2025 and Aug 21, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (5 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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Insufficient Flow or Under Infusion5
Loose or Intermittent Connection5
Patient Device Interaction Problem5

Patient problems

Insufficient Information5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 21, 2025Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Patient Device Interaction Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIRST OF FIVE REPORTS. REFER TO 3004748541-2025-00046 FOR THE SECOND REPORT. REFER TO 3004748541-2025-00047 FOR THE THIRD REPORT. REFER TO 3004748541-2025-00048 FOR THE FOURTH REPORT. REFER TO 3004748541-2025-00049 FOR THE FIFTH REPORT. IT WAS DISCOVERED DURING PATIENT USE, THE MASK DID NOT FIT PROPERLY, THE NEBULIZER DID NOT MIST RIGHT AND THE OXYGEN (O2) TUBING POPPED OFF. THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 22867359 ↗
MalfunctionAug 21, 2025Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Patient Device Interaction Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE SECOND OF FIVE REPORTS. REFER TO 3004748541-2025-00045 FOR THE FIRST REPORT. REFER TO 3004748541-2025-00047 FOR THE THIRD REPORT. REFER TO 3004748541-2025-00048 FOR THE FOURTH REPORT. REFER TO 3004748541-2025-00049 FOR THE FIFTH REPORT. IT WAS DISCOVERED DURING PATIENT USE, THE MASK DID NOT FIT PROPERLY, THE NEBULIZER DID NOT MIST RIGHT AND THE OXYGEN (O2) TUBING POPPED OFF. THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 22866172 ↗
MalfunctionAug 21, 2025Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Patient Device Interaction Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE THIRD OF FIVE REPORTS. REFER TO 3004748541-2025-00045 FOR THE FIRST REPORT. REFER TO 3004748541-2025-00046 FOR THE SECOND REPORT. REFER TO 3004748541-2025-00048 FOR THE FOURTH REPORT. REFER TO 3004748541-2025-00049 FOR THE FIFTH REPORT. IT WAS DISCOVERED DURING PATIENT USE, THE MASK DID NOT FIT PROPERLY, THE NEBULIZER DID NOT MIST RIGHT AND THE OXYGEN (O2) TUBING POPPED OFF. THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 22866171 ↗
MalfunctionAug 21, 2025Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Patient Device Interaction Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FIFTH OF FIVE REPORTS. REFER TO 3004748541-2025-00045 FOR THE FIRST REPORT. REFER TO 3004748541-2025-00046 FOR THE SECOND REPORT. REFER TO 3004748541-2025-00047 FOR THE THIRD REPORT. REFER TO 3004748541-2025-00048 FOR THE FOURTH REPORT. IT WAS DISCOVERED DURING PATIENT USE, THE MASK DID NOT FIT PROPERLY, THE NEBULIZER DID NOT MIST RIGHT AND THE OXYGEN (O2) TUBING POPPED OFF. THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 22866170 ↗
MalfunctionAug 21, 2025Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Patient Device Interaction Problem; Loose or Intermittent Connection; Insufficient Flow or Under Infusion; Patient Device Interaction Problem
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED FIVE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FIVE DIFFERENT PATIENTS. THIS IS THE FOURTH OF FIVE REPORTS. REFER TO 3004748541-2025-00045 FOR THE FIRST REPORT, REFER TO 3004748541-2025-00046 FOR THE SECOND REPORT , REFER TO 3004748541-2025-00047 FOR THE THIRD REPORT , REFER TO 3004748541-2025-00049 FOR THE FIFTH REPORT. IT WAS DISCOVERED DURING PATIENT USE, THE MASK DID NOT FIT PROPERLY, THE NEBULIZER DID NOT MIST RIGHT AND THE OXYGEN (O2) TUBING POPPED OFF. THERE WAS NO REPORTED INJURY.
Patient problems: Insufficient Information
MAUDE report 22866169 ↗

Device details

UDI-DI	`00607411102028`
Brand	N/A
Model	8904-7
Company	Salter Labs
Product code	CCQ · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 16, 2026

Device type (GMDN): Therapeutic agent nebulizer, benchtop

An assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.

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All NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) devices →

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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