LMA ATOMIZATIONRecalls & reported problems across all models
Teleflex Incorporated · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 5 models of LMA ATOMIZATION by Teleflex Incorporated in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2021 and Aug 7, 2026 — classified as 2 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LMA ATOMIZATION problems
Device problems
- Material Discolored6
- Complete Blockage5
- Material Separation4
- Break3
- Product Quality Problem3
- Unsealed Device Packaging3
- Contamination /Decontamination Problem2
- Device Markings/Labelling Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- Insufficient Information2
LMA ATOMIZATION models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LMA ATOMIZATION IPN915303NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)18 reports
- LMA ATOMIZATION IPN048826NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)11 reports
- LMA ATOMIZATION IPN915310APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA2 reports
- LMA ATOMIZATION IPN048838APPLICATOR (LARYNGO-TRACHEAL), TOPICAL ANESTHESIA1 report
- LMA ATOMIZATION IPN049182NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)1 report
Recent LMA ATOMIZATION adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 7, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50173122 ↗InjuryApr 8, 2026Material Separation
IT WAS REPORTED THAT: "THE DEVICE TIP FELL OUT INTO A PATIENTS AIRWAY. IT WAS RETRIEVED BY A BRONCOSCOPE. THE PATIENT WAS NOT HARMED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24815495 ↗MalfunctionNov 3, 2025Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional
IT WAS REPORTED THAT " MISSING MODEL AND LOT DATA ON THE PACKAGING. THE ISSUE WAS IDENTIFIED AT INCOMING INSPECTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23449117 ↗MalfunctionApr 24, 2025Material Discolored; Material Discolored
IT WAS REPORTED THAT " STAIN ON THE NASAL ADAPTOR. THE ISSUE WAS IDENTIFIED DURING INCOMING INSPECTION." ASSOCIATED COMPLAINTS: "300 3898360-2025-00355, 3003898360-2025-00347 AND 3003898360-2025-00354.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898190 ↗MalfunctionApr 24, 2025Material Discolored; Material Discolored
IT WAS REPORTED THAT " STAIN ON THE NASAL ADAPTOR. THE ISSUE WAS IDENTIFIED DURING INCOMING INSPECTION." ASSOCIATED COMPLAINTS: "300 3898360-2025-00355, 3003898360-2025-00347."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898175 ↗MalfunctionApr 24, 2025Material Discolored; Material Discolored
FAILURE MODE "FOREIGN MATERIAL - STAIN" COULD BE CONFIRMED WITH PICTURE ATTACHED. HOWEVER IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION, DETERMINATE THE ROOT CAUSE & CORRECTIVE ACTIONS. IF THE COMPLAINT SAMPLES BECOME AVAILABLE AT A LATER DATE, THIS COMPLAINT WILL BE UPDATED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898073 ↗MalfunctionApr 24, 2025Material Discolored; Material Discolored
IT WAS REPORTED THAT " STAIN ON THE NASAL ADAPTOR. THE ISSUE WAS IDENTIFIED DURING INCOMING INSPECTION." ASSOCIATED COMPLAINTS: "300 3898360-2025-00355, 3003898360-2025-00347 AND 3003898360-2025-00354.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898044 ↗MalfunctionApr 24, 2025Material Discolored; Material Discolored
IT WAS REPORTED THAT " STAIN ON THE NASAL ADAPTOR. THE ISSUE WAS IDENTIFIED DURING INCOMING INSPECTION." ASSOCIATED COMPLAINTS: "3003898360-2025-00355, 3003898360-2025-00347 AND 3003898360-2025-00354.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898026 ↗MalfunctionApr 24, 2025Material Discolored; Material Discolored
IT WAS REPORTED THAT " STAIN ON THE NASAL ADAPTOR. THE ISSUE WAS IDENTIFIED DURING INCOMING INSPECTION." ASSOCIATED COMPLAINTS: "300 3898360-2025-00355 AND 3003898360-2025-00354."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898014 ↗MalfunctionMar 6, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT "MISSING DATA ON THE PRIMARY PACKAGING. THE ISSUE WAS IDENTIFIED DURING INCOMING INSPECTION. THERE WAS NO PATIENT INVOLVED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21534489 ↗MalfunctionMar 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT "FOREIGN MATERIAL IN THE PRIMARY PACKAGING. THE ISSUE WAS IDENTIFIED DURING INCOMING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21534361 ↗MalfunctionMar 6, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT "STAIN ON THE NASAL ADAPTOR. THE ISSUE WAS IDENTIFIED ON INCOMING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21534097 ↗MalfunctionMar 5, 2025Lack of Maintenance Documentation or Guidelines; Lack of Maintenance Documentation or Guidelines
IT WAS REPORTED THAT "MISSING DATA ON THE LABEL. ISSUE WAS IDENTIFIED PRIOR TO USE. ASSOCIATED COMPLAINTS 3003898360-2025-00206, 3003898360-2025-00242 AND 3003898360-2025-00243.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21524186 ↗MalfunctionMar 4, 2025Lack of Maintenance Documentation or Guidelines; Lack of Maintenance Documentation or Guidelines
IT WAS REPORTED THAT "MISSING DATA ON THE LABEL. ISSUE WAS IDENTIFIED PRIOR TO USE. ASSOCIATED COMPLAINTS 3003898360-2025-00206, 300 3898360-2025-00242 .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514793 ↗MalfunctionMar 4, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT "MISSING DATA ON THE LABEL".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21514093 ↗
Other Teleflex Incorporated products
- ARROW1,494 models · 9,043 reports · 62 recalls
- RUSCH220 models · 436 reports · 130 recalls
- WECK97 models · 3,790 reports · 1 recall
- HUDSON RCI152 models · 1,461 reports · 7 recalls
- LANGSTON4 models · 15 reports · 5 recalls
- PLEUR-EVAC15 models · 146 reports · 1 recall
- LMA AIRWAY MANAGEMENT47 models · 139 reports
- UROLIFT13 models · 137 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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