AirLife™ 2K8004Recalls & reported problems
Airlife · Adult Manual Resuscitator • Oxygen Reservoir Bag, Adult Mask · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10190752114104), received between Sep 24, 2021 and Oct 23, 2025 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Jan 10, 2024Class IOpen, Classified
Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.
Z-1065-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Inflation Problem2
- Defective Device1
- Gas/Air Leak1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
- Pulmonary Infarction1
- Respiratory Insufficiency1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED, WHEN THE RESERVOIR BAG, ON THE ADULT RESUSCITATOR MASK WAS SQUEEZED, AIR ESCAPED. THERE WAS NO REPORTED INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23375232 ↗InjuryJun 21, 2024Material Integrity Problem; Material Integrity Problem
RESERVOIR BAG FAILED TO INFLATE WHILE BEING ATTACHED TO HIGH FLOW OXYGEN. PATIENT WAS ADMITTED TO THE ICU.
Patient problems: Respiratory Insufficiency
MAUDE report 19586649 ↗InjuryJan 19, 2024Inflation Problem; Inflation Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 2K8004 - RESUS, ADLT W/MASK, RESV BAG, 6/CS DID NOT INFLATE WHILE THE PATIENT WAS CODING. THE NURSE PULLED ANOTHER BAG, AND IT ALSO WOULDN'T INFLATE. A SECOND AND THIRD BAG WERE PULLED, AND THEY ALSO DID NOT INFLATE. FINALLY, THE FOURTH BAG INFLATED. THE PATIENT'S IMPACT OR HARM IS CURRENTLY UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18544358 ↗MalfunctionNov 7, 2021Inflation Problem; Inflation Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 2K8004- AIRLIFE¿ ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT M DID NOT INFLATE DUE TO MISSING PARTS. THIS ISSUE OCCURRED WHILE USED ON A PATIENT. AS AN INTERVENTION, THE SAMPLE WAS REPLACED. AT THIS TIME, THERE IS NO INFORMATION ON PATIENT OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12763360 ↗InjurySep 24, 2021Defective Device; Defective Device
THE CUSTOMER REPORTED THAT THE 2K8004 RESUS, ADLT W/MASK, RESV BAG RESERVOIR ON THE AMBU BAGS WAS WRAPPED AT THE DISTAL END OPENING WHERE THE TUBING GOES THROUGH THE RESERVOIR, IT WAS FOLDED OVER BLOCKING AIR FROM ESCAPING CAUSING EXCESSIVE PRESSURES WHICH RESULTED IN A PNEUMOTHORAX WITH ONE PATIENT.
Patient problems: Pulmonary Infarction
MAUDE report 12525437 ↗
Other Cardiopulmonary resuscitation aid kit devices
- Ambu® SPUR® II Pediatric Resuscitator 531600051Ambu A/S · Cardiopulmonary resuscitation aid kit1 recall10 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
- Ambu® SPUR® II Adult Resuscitator 524611031Ambu 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 · each recall links to the FDA recall notice
- 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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