AirLife™ 2K8004FRecalls & reported problems
Airlife · AirLife™ Manual Resuscitator Adult Manual Resuscitator Oxygen Reservoir Bag, Adult Mask, Expiratory Filter · 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752114135), received between Jun 19, 2020 and Jun 19, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).
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.
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-1059-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Loose or Intermittent Connection1
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.
InjuryJun 19, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED THAT THE OXYGEN TUBING GOT DISCONNECTED FROM THE WALL (O2 SOURCE) WHEN THE O2 PRESSURE INCREASED. A GAS LEAK WAS THEN OBSERVED FROM THE AIRLIFE ADULT MANUAL RESUSCITATOR. IT HAPPENED DURING PATIENT USE, AND THE INSUFFLATOR WAS REPLACED WITH A DIFFERENT BRAND. THE INCIDENT DID NOT CAUSE ANY HARM BUT DID DELAY TREATMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10176899 ↗
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
- 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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