Disposable Face Mask 000252956Recalls & reported problems
Ambu A/S · Face mask · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05707480023363), received between Apr 23, 2026 and Apr 23, 2026 — classified as 4 injuries.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (4 reports).
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
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size4
Patient problems
- Hypoxia4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2026Inadequacy of Device Shape and/or Size
IT WAS DIFFICULT TO VENTILATE THE PATIENT, AS THE MASK WAS NOT ADHERING CORRECTLY TO PATIENT'S FACE. PATIENT DESATURATED DURING ANESTHESIA INDUCTION. PATIENT HAD TO BE VENTILATED BY TWO PEOPLE SIMULTANEOUSLY AS THERE WAS SEVERE DESATURATION.
Patient problems: Hypoxia
MAUDE report 24971272 ↗InjuryApr 23, 2026Inadequacy of Device Shape and/or Size
IT WAS DIFFICULT TO VENTILATE THE PATIENT DURING INDUCTION. THIS LED TO A QUICK DESATURATION. THE MASK WAS NOT ADHERING WELL TO PATIENT'S FACE. IT WAS DIFFICULT TO VENTILATE THE PATIENT DURING INDUCTION. THIS LED TO A QUICK DESATURATION. THE MASK WAS NOT ADHERING WELL TO PATIENT'S FACE.
Patient problems: Hypoxia
MAUDE report 24970440 ↗InjuryApr 23, 2026Inadequacy of Device Shape and/or Size
IT WAS DIFFICULT TO VENTILATE THE PATIENT, AS THE MASK WAS NOT ADHERING CORRECTLY TO PATIENT'S FACE. PATIENT DESATURATED DURING ANESTHESIA INDUCTION. PATIENT HAD TO BE VENTILATED BY TWO PEOPLE SIMULTANEOUSLY AS THERE WAS SEVERE DESATURATION.
Patient problems: Hypoxia
MAUDE report 24961948 ↗InjuryApr 23, 2026Inadequacy of Device Shape and/or Size
IT WAS DIFFICULT TO VENTILATE THE PATIENT DURING INDUCTION. THIS LED TO A QUICK DESATURATION. THE MASK WAS NOT ADHERING WELL TO PATIENT'S FACE. IT WAS DIFFICULT TO VENTILATE THE PATIENT DURING INDUCTION. THIS LED TO A QUICK DESATURATION. THE MASK WAS NOT ADHERING WELL TO PATIENT'S FACE.
Patient problems: Hypoxia
MAUDE report 24961932 ↗
Other MASK, OXYGEN devices
- HUDSON RCI HUDRHO41UMedline Industries, Inc. · MASK, OXYGEN1 recall27 reports
- HUDSON RCI HUD1930Medline Industries, Inc. · MASK, OXYGEN1 recall12 reports
- Mask, Adult Aerosol, Vented 0250Westmed, Inc. · Mask, Oxygen8 reports
- AcuCare 60788Resmed Pty Ltd · Mask, Oxygen4 reports
- F&P FlexiTrunk BC801-10Fisher & Paykel Healthcare Limited · Mask, Oxygen4 reports
- HUDSON RCI HUD1007Medline Industries, Inc. · MASK, OXYGEN4 reports
- F&P FlexiTrunk BC802-10Fisher & Paykel Healthcare Limited · Mask, Oxygen2 reports
- AcuCare 60786Resmed Pty Ltd · Mask, Oxygen2 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
- 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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