Vital Signs™ 5210Recalls & reported problems
Airlife · Vital Signs™ Neonate Face Mask Size 1 · Class 1
All models of Vital Signs (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483585542), received between Feb 12, 2026 and Feb 12, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Seal” (1 report).
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
- Failure to Seal1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 12, 2026Failure to Seal
IT WAS REPORTED THAT THE FACE MASK LOSES AIR AT THE SEAL OVER TIME. THESE MASKS ARE USED TO VENTILATE PATIENTS WITH EITHER THE NEO TEE OR AMBU BAGS, AND WHEN DEFLATED, THEY FAIL TO MAINTAIN AN ADEQUATE SEAL AND MAY CAUSE SKIN INJURY. NO INJURY WAS REPORTED, AND THERE WAS NO REPORT OF ANY DELAY IN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24328531 ↗
Other Mask, Gas, Anesthetic devices
- Ventlab BT2034Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT2029Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT2032Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT2220Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT3034Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT2415KVentlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4022Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT2014Ventlab, LLC · Mask, Gas, Anesthetic1 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 · 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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