AirLife 2K8805Recalls & reported problems
Carefusion Corporation · Adult Manual Resuscitator; 40" (1.0m) Oxygen Resevoir Tubing, Adult Mask · Class 2
All models of AirLife (23)
Data updated Oct 18, 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 10885403006678), received between May 5, 2021 and May 5, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical 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 18, 2026.
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- 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.
InjuryMay 5, 2021Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE AIRLIFE¿ ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT MASK EXPERIENCED PATIENT AMBU BAG WAS NOT SEEMING TO FILL WITH AIR OR THERE WAS NO RESISTING OF THE BAG. PATIENT O2 SATURATION DROPPED. AS AN INTERVENTION, DIFFERENT AMBU BAG WAS USED.
Patient problems: Low Oxygen Saturation
MAUDE report 11780670 ↗
Other Cardiopulmonary Resuscitation Aid Kit devices
- Ambu® SPUR® II Pediatric Resuscitator 531600051Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall10 reports
- AirLife™ 2K8004Airlife · Cardiopulmonary resuscitation aid kit1 recall5 reports
- AirLife™ 2K8005Airlife · Cardiopulmonary resuscitation aid kit1 recall1 death4 reports
- Ambu® SPUR® II Adult Resuscitator 523611051Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall3 reports
- AirLife™ 2K8017Airlife · Cardiopulmonary resuscitation aid kit1 recall1 death2 reports
- AirLife™ 2K8004FAirlife · Cardiopulmonary resuscitation aid kit1 recall1 report
- Ambu® SPUR® II Pediatric Resuscitator 530213031Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Pediatric Resuscitator 530613071Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall0 reports
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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