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AirLife™ 2K8020Recalls & reported problems

Airlife · AirLife™ Pediatric Manual Resuscitator Oxygen Reservoir Bag, Pediatric Mask, Pressure Limiting Valve with Lock · Class 1

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752114326), received between Mar 2, 2020 and Mar 2, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (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 16, 2026.

Most reported problems

Device problems

  • Defective Device1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 2, 2020Defective Device; Defective Device

    THE CUSTOMER REPORTED THAT THE AIRLIFE PEDIATRIC MANUAL RESUSCITATOR EXPERIENCED A PEDIATRIC BAG FAILURE DURING PATIENT USE. THE CUSTOMER CONFIRMED THAT THE PROBLEM WAS QUICKLY IDENTIFIED AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT. AS AN INTERVENTION, THEY GOT ANOTHER PEDIATRIC BAG AND IT WORKED JUST FINE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9777329 ↗

Other Anesthesia breathing circuit kit (adult & pediatric) devices

All Anesthesia breathing circuit kit (adult & pediatric) devices →

Sources and updates

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