AespireRecalls & reported problems across all models
Datex-Ohmeda Inc · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one Aespire model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 206
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 4
We found 2 models of Aespire by Datex-Ohmeda Inc in the FDA's device registry (GUDID). Together they are named in 206 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2018 and Sep 29, 2026 — classified as 206 malfunctions.
The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (36 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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
Aespire 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 12, 2024Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Z-0077-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 12, 2024Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Z-0076-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 12, 2024Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Z-0075-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Jul 12, 2024Open, Classified
Potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port.
Z-0074-2025 · Root cause: Device Design · Recall details · FDA record ↗
Most reported Aespire problems
Device problems
- Therapeutic or Diagnostic Output Failure36
- Failure to Run on Battery34
- Mechanical Problem25
- Gas/Air Leak14
- Insufficient Flow or Under Infusion14
- Power Problem14
- Unexpected Therapeutic Results14
- Electrical /Electronic Property Problem12
Patient problems
- No Clinical Signs, Symptoms or Conditions185
- No Patient Involvement11
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient1
Aespire models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Aespire ViewGas-machine, anesthesia1 recall158 reports
- Aespire 7900Gas-machine, anesthesia3 recalls48 reports
Recent Aespire adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928101 ↗MalfunctionSep 28, 2026Therapeutic or Diagnostic Output Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914506 ↗MalfunctionSep 25, 2026Mechanical Problem
It was reported that there was a malfunction during a case resulting inloss of ventilation. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900415 ↗MalfunctionSep 24, 2026Therapeutic or Diagnostic Output Failure
It was reported that there was an error resulting in loss of mechanical ventilation during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881414 ↗MalfunctionSep 8, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675151 ↗MalfunctionJul 27, 2026No Flow
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50034446 ↗MalfunctionJul 1, 2026No Flow
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF OXYGEN DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679677 ↗MalfunctionJun 24, 2026Power Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POTENTIAL POWER FAILURE DURING SERVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25607342 ↗MalfunctionJun 10, 2026Increase in Pressure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING A CASE RESULTING IN PROLONGED EXCESSIVE PRESSURE DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25458566 ↗MalfunctionJun 3, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25372994 ↗MalfunctionMay 22, 2026Failure to Run on Battery
IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25260474 ↗MalfunctionMay 8, 2026Therapeutic or Diagnostic Output Failure
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AN ERROR THAT RESULTS IN AN INABILITY TO INITIATE MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124869 ↗MalfunctionMay 6, 2026Mechanical Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AN INABILITY TO SWITCH VENTILATION MODES AS EXPECTED DURING A CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25092535 ↗MalfunctionMay 4, 2026Insufficient Flow or Under Infusion
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT OXYGEN OR FRESH GAS FLOW DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073834 ↗MalfunctionMay 1, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN AN OVER DELIVERY OF TIDAL VOLUME. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25058399 ↗
Other Datex-Ohmeda Inc products
All Datex-Ohmeda Inc 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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