Ambu® SPUR® II Pediatric Resuscitator 530614017Recalls & reported problems
Ambu A/S · w/Expiratory Filter & Manometer · Class 2
All models of Ambu SPUR II Pediatric Resuscitator (26)
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
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
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
- 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 ↗
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
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page