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AirLife™ CK4510Recalls & reported problems

Airlife · Prefill Nebulizer Kit · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752152090), received between Oct 16, 2021 and Oct 16, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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

Device problems

  • Fluid/Blood Leak1
  • Leak/Splash1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 16, 2021Leak/Splash; Leak/Splash

    THE CUSTOMER REPORTED THAT THE NEB KIT W ADAPTER 0.45% NACL 1000ML EXPERIENCED SPUTTERING OF WATER OUT OF THE TIP OF THE BOTTLE WHEN MIST STOPPED. AS OF THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12643922 ↗
  • MalfunctionOct 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

    THE CUSTOMER REPORTED THAT WHILE USING THE NEBULIZER, THE UNIT FAILED TO PROVIDE MIST. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12643800 ↗

Other Humidifier nebulizer kit devices

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Sources and updates

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