LMA ATOMIZATION IPN915303Recalls & reported problems
Teleflex Incorporated · MAD Nasal with 3mL Syringe · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 14026704709813), received between Jan 7, 2025 and Nov 3, 2025 — classified as 18 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Discolored6
- Complete Blockage3
- Product Quality Problem3
- Contamination /Decontamination Problem2
- Device Markings/Labelling Problem2
- Lack of Maintenance Documentation or Guidelines2
- Delivered as Unsterile Product1
- Inadequate Instructions for Healthcare Professional1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionMar 4, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT "STAIN ON THE PRIMARY PACKAGING. THE ISSUE WAS IDENTIFIED AT INCOMING INSPECTION /INVENTORY REVIEW. THERE WAS NO PATIENT INVOLVED."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21512840 ↗MalfunctionMar 4, 2025Unsealed Device Packaging; Unsealed Device Packaging
IT WAS REPORTED THAT: "INCOMPLETE SEALING OF THE PACKAGING. THE ISSUE WAS IDENTIFIED AT INCOMING INSPECTION /INVENTORY REVIEW."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21512826 ↗MalfunctionJan 7, 2025Complete Blockage; Product Quality Problem; Complete Blockage; Product Quality Problem
IT WAS REPORTED THAT: "CONE OF THE NASAL CONNECTOR COMPLETELY CLOSED. ALSO, OTHERS FROM VE WITH THE SAME PRODUCTION ERROR. THERE WAS NO PATIENT INVOLVED" ASSOCIATED COMPLAINTS 3003898360-2025-00028, 3003898360-2025-00029 AND (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21089142 ↗MalfunctionJan 7, 2025Complete Blockage; Product Quality Problem; Complete Blockage; Product Quality Problem
IT WAS REPORTED THAT: "CONE OF THE NASAL CONNECTOR COMPLETELY CLOSED. ALSO, OTHERS FROM VE WITH THE SAME PRODUCTION ERROR. THERE WAS NO PATIENT INVOLVED." ASSOCIATED COMPLAINTS 3003898360-2025-00028, 3003898360-2025-00029 AND (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21089121 ↗MalfunctionJan 7, 2025Complete Blockage; Product Quality Problem; Complete Blockage; Product Quality Problem
IT WAS REPORTED THAT: "CONE OF THE NASAL CONNECTOR COMPLETELY CLOSED. ALSO OTHERS FROM VE WITH THE SAME PRODUCTION ERROR." ASSOCIATED COMPLAINTS 3003898360-2025-00028, .AND (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21089103 ↗
Other NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) devices
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- Salter AIRE Elite SO-1774BESalter Labs · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)7 reports
- N/A 8904-7Salter Labs · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)5 reports
- HUDSON RCI IPN049826Teleflex Incorporated · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)1 report
- LMA ATOMIZATION IPN049182Teleflex Incorporated · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)1 report
- AirLife™ 441HAirlife · NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)1 report
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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