Ambu® SPUR® II Adult Resuscitator 523611051Recalls & reported problems
Ambu A/S · w/Mercury Filter · Class 2
All models of Ambu SPUR II Adult Resuscitator (11)
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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05707480149513), received between Nov 14, 2024 and Jul 31, 2026 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (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
- Jul 9, 2025Class IOpen, Classified
Potential for the manometer port being blocked rendering the manometer non-functional.
Z-2181-2025 · Root cause: Equipment maintenance · Recall details · FDA record ↗
Most reported problems
Device problems
- Gas/Air Leak2
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 31, 2026Detachment of Device or Device Component
As per customer: Appliation: Ventilating intubated patient. Emergency pressure release valve came out of housing, separating completely from BMV unit, unable to generate positive pressure to ventilate patient. Patient outcome unknown.
Patient problems: Insufficient Information
MAUDE report 50096870 ↗InjuryNov 14, 2024Gas/Air Leak; Gas/Air Leak
PATIENT WAS INVOLVED, HOWEVER WE WERE UNABLE TO OBTAIN ANY INFORMATION ON PATIENT CONDITION. THE CUSTOMER REPORTED LEAKING AROUND THE POP OFF VALVE WHEN IN USE, EVEN AT LOW PRESSURES. THIS HAS BEEN AN ONGOING ISSUE FOR MONTHS AND THE CUSTOMER REPORTED IT AS AN INTERMITTENT ISSUE.
Patient problems: Insufficient Information
MAUDE report 20685921 ↗MalfunctionNov 14, 2024Gas/Air Leak; Gas/Air Leak
PATIENT WAS INVOLVED, HOWEVER WE WERE UNABLE TO OBTAIN ANY INFORMATION ON PATIENT CONDITION. THE CUSTOMER REPORTED LEAKING AROUND THE POP OFF VALVE WHEN IN USE, EVEN AT LOW PRESSURES. THIS HAS BEEN AN ONGOING ISSUE FOR MONTHS AND THE CUSTOMER REPORTED IT AS AN INTERMITTENT ISSUE.
Patient problems: Insufficient Information
MAUDE report 20682199 ↗
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
- 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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