SPUR Adult ResuscitatorRecalls & reported problems across all models
Ambu A/S · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one SPUR Adult Resuscitator model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 4 models of SPUR Adult Resuscitator by Ambu A/S in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Aug 14, 2025 and Feb 2, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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
SPUR 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 2 of these models · Recall details · FDA record ↗
Most reported SPUR Adult Resuscitator problems
Device problems
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Low Oxygen Saturation1
SPUR Adult Resuscitator models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPUR® Adult Resuscitator 523611051EVentilator, emergency, manual (resuscitator)1 recall0 reports
- SPUR® Adult Resuscitator 524611051Ventilator, emergency, manual (resuscitator)1 recall0 reports
- SPUR® Adult Resuscitator 520611048EVentilator, emergency, manual (resuscitator)2 reports
- SPUR® Adult Resuscitator 520611061Ventilator, emergency, manual (resuscitator)1 report
Recent SPUR Adult Resuscitator adverse event reports
The 3 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026
DURING VENTILATION WITH NURSING AND ANESTHESIA, OXYGEN SATURATIONS CONTINUED TO DECLINE WHEN IT WAS NOTICED THAT AMBU FACE MASK WAS ATTACHED TO WHERE THE PEEP [POSITIVE END EXPIRATORY PRESSURE] VALVE ATTACHES.
Patient problems: Low Oxygen Saturation
MAUDE report 24230208 ↗MalfunctionAug 14, 2025Material Deformation; Material Deformation
PER THE CUSTOMER: "TODAY DURING A FULL ARREST WITH T20, THEY HAD TO SEND A MEMBER OUT TO THE MEDIC UNIT TO GRAB A NEW AMBU BAG BECAUSE THE ONE THEY WERE USING COLLAPSED AND WILL NOT EXPAND. THE SECOND AMBU BAG WHICH THEY GRABBED FROM A MEDIC UNIT WORKED FLAWLESSLY." AMBU BAG WAS DEFLATED UPON OPENING, WOULD NOT SUFFICIENTLY FILL THE BAG. WHEN CINCINNATI FIRE ARRIVED ON THE SCENE, THE PATIENT WAS TOO FAR GONE ALREADY. A SECOND BAG WAS USED AND WORKED AS INDICATED. PATIENT EXPIRED. THE BAGS MALFUNCTION DID NOT CONTRIBUTE TO THE PATIENTS OUTCOME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22808402 ↗MalfunctionAug 14, 2025Material Deformation; Material Deformation
PER THE CUSTOMER: "TODAY DURING A FULL ARREST WITH T20, THEY HAD TO SEND A MEMBER OUT TO THE MEDIC UNIT TO GRAB A NEW AMBU BAG BECAUSE THE ONE THEY WERE USING COLLAPSED AND WILL NOT EXPAND. THE SECOND AMBU BAG WHICH THEY GRABBED FROM A MEDIC UNIT WORKED FLAWLESSLY." AMBU BAG WAS DEFLATED UPON OPENING, WOULD NOT SUFFICIENTLY FILL THE BAG. WHEN CINCINNATI FIRE ARRIVED ON THE SCENE, THE PATIENT WAS TOO FAR GONE ALREADY. THE BAG WAS NOT RESPONSIBLE FOR PATIENTS' DEATH. A SECOND BAG WAS USED AND WORKED AS INDICATED. PATIENT EXPIRED. THE BAG WAS NOT RESPONSIBLE FOR PATIENTS' DEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22802795 ↗
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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