Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
FDA adverse event reports and recall history for nebulizer, medicinal, non-ventilatory (atomizer) (product code CCQ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 623
- Deaths
- 2
- Injuries
- 52
- Malfunctions
- 425
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2016-11-09TerminatedProcess control
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
- 2016-11-09TerminatedProcess control
FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
- 2016-11-09TerminatedProcess control
FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
- 2016-11-09TerminatedProcess control
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
- 2016-11-09TerminatedProcess control
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
- 2013-05-29TerminatedNonconforming Material/Component
EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
- 2013-05-29TerminatedNonconforming Material/Component
AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
- 2013-05-29TerminatedNonconforming Material/Component
EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.
Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard.
- 2011-10-26TerminatedEquipment maintenance
Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.
A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
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