Ambu SPUR II Adult ResuscitatorRecalls & reported problems across all models
Ambu A/S · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Ambu SPUR II Adult Resuscitator model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 1
We found 11 models of Ambu SPUR II Adult Resuscitator by Ambu A/S in the FDA's device registry (GUDID). Together they are named in 15 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2023 and Jul 31, 2026 — classified as 4 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Component Missing” (7 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Ambu SPUR II Adult Resuscitator recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jul 9, 2025Class IOpen, Classified
Potential for the manometer port being blocked rendering the manometer non-functional.
Z-2181-2025 · Root cause: Equipment maintenance · names 7 of these models · Recall details · FDA record ↗
Most reported Ambu SPUR II Adult Resuscitator problems
Device problems
- Component Missing7
- Break2
- Gas/Air Leak2
- Mechanical Jam2
- Detachment of Device or Device Component1
- Inflation Problem1
- Infusion or Flow Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information5
- Respiratory Failure1
Ambu SPUR II Adult Resuscitator models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Ambu® SPUR® II Adult Resuscitator 523611051Cardiopulmonary resuscitation aid kit1 recall3 reports
- Ambu® SPUR® II Adult Resuscitator 524611001Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 524611011Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 524611031Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 524611047Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 523211000Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 524611000Cardiopulmonary resuscitation aid kit1 recall0 reports
- Ambu® SPUR® II Adult Resuscitator 520611000Cardiopulmonary resuscitation aid kit7 reports
- Ambu® SPUR® II Adult Resuscitator 520211000Cardiopulmonary resuscitation aid kit2 reports
- Ambu® SPUR® II Adult Resuscitator 521611000Cardiopulmonary resuscitation aid kit2 reports
- Ambu® SPUR® II Adult Resuscitator 523611030Cardiopulmonary resuscitation aid kit1 report
Recent Ambu SPUR II Adult Resuscitator adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionMay 22, 2026Component Missing
THE CUSTOMER STATED WHEN HE OPENED THE PLASTIC BAG FOR PATIENT USE THERE WAS NO MASK INSIDE THE BAG. NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25257619 ↗MalfunctionMay 22, 2026Component Missing
THE CUSTOMER STATED WHEN HE OPENED THE PLASTIC BAG FOR PATIENT USE THERE WAS NO MASK INSIDE THE BAG. NO IMPACT TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25251195 ↗MalfunctionApr 8, 2026Component Missing
AN AMBU SPUR II WAS IDENTIFIED AS DEFECTIVE SUPPLY. THE PRODUCT SHOULD BE SUPPLIED WITH MASK FOR BAGGING PATIENTS. FACEMASK WAS NOT INCLUDED, THIS SUPPLY DID NOT REACH A PATIENT, THIS IS THE SECOND TIME THIS HAS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820793 ↗MalfunctionApr 8, 2026Component Missing
AN AMBU SPUR II WAS IDENTIFIED AS DEFECTIVE SUPPLY. THE PRODUCT SHOULD BE SUPPLIED WITH MASK FOR BAGGING PATIENTS. FACEMASK WAS NOT INCLUDED, THIS SUPPLY DID NOT REACH A PATIENT, THIS IS THE SECOND TIME THIS HAS OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24814477 ↗MalfunctionFeb 13, 2026Component Missing
CUSTOMER HAD A SEALED AMBU SPUR II ADULT RESUSCITATOR THAT DID NOT HAVE A MASK IN THE SEALED PACKAGE. PATIENT CONDITION WAS NOT AFFECTED, ATTEMPTED TO BE USED ON A PATIENT, BUT THE NURSE WAS UNABLE TO DUE TO THE MISSING MASK. SHE HAD TO GO GET ANOTHER AMBU BAG FROM A DIFFERENT CRASH CART. THERE WAS A SLIGHT DELAY IN PATIENT CARE, BUT THE PATIENT'S CARE WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24336841 ↗MalfunctionFeb 13, 2026Component Missing
CUSTOMER HAD A SEALED AMBU SPUR II ADULT RESUSCITATOR THAT DID NOT HAVE A MASK IN THE SEALED PACKAGE. PATIENT CONDITION WAS NOT AFFECTED, ATTEMPTED TO BE USED ON A PATIENT, BUT THE NURSE WAS UNABLE TO DUE TO THE MISSING MASK. SHE HAD TO GO GET ANOTHER AMBU BAG FROM A DIFFERENT CRASH CART. THERE WAS A SLIGHT DELAY IN PATIENT CARE, BUT THE PATIENT'S CARE WAS NOT AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24330063 ↗MalfunctionSep 5, 2025Component Missing
UNOPENED AMBU-BAG REMOVED FROM SEALED PACKAGING FOUND TO BE MISSING FACE MASK PORTION OF THE DEVICE DELAYING PATIENT CARE UNTIL A NEW DEVICE COULD BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22976491 ↗InjuryMay 29, 2025Break; Break
THE CUSTOMER REPORTED: PATIENT NEEDED AN EMERGENCY AIRWAY. WHEN ANESTHESIA WENT TO GET THE AMBU BAG, THEY WERE NOT ABLE TO OXYGENATE THE PATIENT DUE TO A HOLE IN THE AMBU BAG. NO PATIENT HARM WAS REPORTED IN THE MDR REPORT (MW5169454) FROM MEDWATCH, BUT THE REPORTS STATES THAT INTERVENTION WAS REQUIRED. DURING AMBU'S FOLLOW-UP CORRESPONDANCE WITH THE CUSTOMER, THE CUSTOMER EXPLAINED THAT THEY REPLACED THE FAULTY AMBU BAG WITH A NEW FUNCTIONAL AMBU BAG. EFFORTS WERE MADE TO OTBAIN FURTHER KNOWLEDGE ON WHETHER THE PATIENT CONDITION WAS AFFECTED BY THE MALFUNCTION. NO RESPONSE WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 22105918 ↗InjuryMay 28, 2025Break; Break
THE CUSTOMER REPORTED: PATIENT NEEDED AN EMERGENCY AIRWAY. WHEN ANESTHESIA WENT TO GET THE AMBU BAG, THEY WERE NOT ABLE TO OXYGENATE THE PATIENT DUE TO A HOLE IN THE AMBU BAG. NO PATIENT HARM WAS REPORTED IN THE MDR REPORT (MW5169454) FROM MEDWATCH, BUT THE REPORTS STATES THAT INTERVENTION WAS REQUIRED. DURING AMBU'S FOLLOW-UP CORRESPONDANCE WITH THE CUSTOMER, THE CUSTOMER EXPLAINED THAT THEY REPLACED THE FAULTY AMBU BAG WITH A NEW FUNCTIONAL AMBU BAG. EFFORTS WERE MADE TO OTBAIN FURTHER KNOWLEDGE ON WHETHER THE PATIENT CONDITION WAS AFFECTED BY THE MALFUNCTION. NO RESPONSE WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 22100039 ↗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 ↗MalfunctionAug 21, 2024Mechanical Jam; Mechanical Jam
ACCORDING TO THE COMPLAINT INFORMATION, DURING THE EVENT OF ADMINISTER RESCUE BREATHS TO A PATIENT IN DESTRESS, THE SPUR II DID NOT DEPRESS PROPERLY. IT WAS CHECHED THAT THE AMBU MASK WAS PROPERLY PLACED MULTIPLE TIMES, AS WELL AS CHECKING THE CONNECTION TO THE OXYGEN FLOWMETER. THE SPUR II WAS THROWN AWAY AND ANOTHER SPUR II WAS OPENED WITH THE SAME ISSUE. PER CUSTOMER: THERE DID NOT APPEAR TO BE ANY DEFORMITIES TO EITHER BAG. EVERYTHING APPEARED TO BE AS IT SHOULD BE. WHEN PLACED ON THE PATIENT'S FACE WE CHECKED SEVERAL TIMES FOR A GOOD SEAL BETWEEN AMBU MASK AND THE PATIENT, A GOOD SEAL WAS MADE, HOWEVER WHEN WE SQUEEZED THE BAG, WE COULD NOT PUSH AIR AT ALL. WE COULDN'T HEAR ANY AIR, NOR COULD WE SEE CHEST RISE AND FALL, THIS HAPPENED WITH BOTH BAGS. TOO MUCH TIME WAS SPENT TRYING TO GET IT TO WORK AND THEREFORE THE ANESTHESIA TEAM ASKED THAT WE DISCONTINUE USE AND ORDER A DIFFERENT BRAND. THE PATIENT DID STABILIZE DESPITE THE MALFUNCTION OF THE AMBU BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20023061 ↗MalfunctionAug 21, 2024Mechanical Jam; Mechanical Jam
ACCORDING TO THE COMPLAINT INFORMATION, DURING THE EVENT OF ADMINISTER RESCUE BREATHS TO A PATIENT IN DISTRESS, THE SPUR II DID NOT DEPRESS PROPERLY. IT WAS CHECKED THAT THE AMBU MASK WAS PROPERLY PLACED MULTIPLE TIMES, AS WELL AS CHECKING THE CONNECTION TO THE OXYGEN FLOWMETER. THE SPUR II WAS THROWN AWAY AND ANOTHER SPUR II WAS OPENED WITH THE SAME ISSUE. PER CUSTOMER: THERE DID NOT APPEAR TO BE ANY DEFORMITIES TO EITHER BAG. EVERYTHING APPEARED TO BE AS IT SHOULD BE. WHEN PLACED ON THE PATIENT'S FACE WE CHECKED SEVERAL TIMES FOR A GOOD SEAL BETWEEN AMBU MASK AND THE PATIENT, A GOOD SEAL WAS MADE, HOWEVER WHEN WE SQUEEZED THE BAG, WE COULD NOT PUSH AIR AT ALL. WE COULDN'T HEAR ANY AIR, NOR COULD WE SEE CHEST RISE AND FALL, THIS HAPPENED WITH BOTH BAGS. TOO MUCH TIME WAS SPENT TRYING TO GET IT TO WORK AND THEREFORE THE ANESTHESIA TEAM ASKED THAT WE DISCONTINUE USE AND ORDER A DIFFERENT BRAND. THE PATIENT DID STABILIZE DESPITE THE MALFUNCTION OF THE AMBU BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20020981 ↗MalfunctionFeb 17, 2023Inflation Problem; Infusion or Flow Problem; Inflation Problem; Infusion or Flow Problem
AMBU BAG DEFLATED AND UNABLE TO GET THE RESUSCITATOR TO EXPAND CORRECTLY TO BE ABLE TO DELIVER AN ADEQUATE FLOW. THE HEALTH PROFESSIONALS UTILIZED ANOTHER AMBU BAG. PATIENT DID NOT SURVIVE THE CODE. ACCORDING TO HEALTH CARE PROFESSIONAL THE PATIENT'S DEMISE WAS NOT RELATED TO THE POOR PERFORMANCE OF THE AMBU BAG, BUT RATHER DUE TO COMORBIDITIES AND A HGB OF 5.
Patient problems: Respiratory Failure
MAUDE report 16395786 ↗
Other Ambu A/S products
All Ambu A/S devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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