Skip to content

AirLife™ 2K8033Recalls & reported problems

Airlife · AirLife™ Adult Manual Resuscitator Oxygen Reservoir Bag, PEEP Valve, without Mask · 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 10190752114364), received between Aug 6, 2024 and Aug 6, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Infusion or Flow Problem1

Patient problems

  • Hypoxia1
  • Low Oxygen Saturation1

Recent adverse event reports

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

  • InjuryAug 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030673-2024-01011 FOR THE FIRST REPORT FDA USER FACILITY MW REPORT MW MW5156100 REPORTED, "DURING ENDOSCOPY, PATIENT BECAME HYPOXIC AND [THE] AMBUBAG WAS USED TO BAG VALVE MASK PATIENT, BUT DESPITE GOOD CHEST RISE AND POSITIVE END TIDAL CARBON DIOXIDE, PATIENT REMAINED HYPOXIC. WHEN [THE] PROVIDER REALIZED [THE] RESERVOIR BAG WAS NOT FULLY INFLATING, DIFFERENT BRAND AMBUBAG USED AND PATIENT'S HYPOXIA IMMEDIATELY RESOLVED...DURING THE DEFECTIVE DEVICE USE, [THE] PATIENT'S SATURATIONS DROPPED AS LOW AS 40%.".

    Patient problems: Hypoxia; Low Oxygen Saturation

    MAUDE report 19918978 ↗

Other Anesthesia breathing circuit kit (adult & pediatric) devices

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

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page