Vital Signs™ A4FX2004Recalls & reported problems
Airlife · Vital Signs™ Adult Anesthesia Breathing Circuit · Class 2
All models of Vital Signs (48)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752119635), received between Nov 18, 2024 and Oct 3, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn
THE CIRCUIT HAS DETACHED AT THE Y/CIRCUIT MULTIPLE TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23216324 ↗MalfunctionNov 27, 2024
THERE IS CONDENSATION VISIBLE INSIDE THE BLUE PLASTIC FILTER CONTAINING PIECE OF A SINGLE USE ADULT ANESTHESIA BREATHING CIRCUIT. THE PACKAGE WAS NOT YET OPEN BUT YOU CAN SEE WATER DROPLETS/CONDENSATION ON THE BLUE PIECE INSIDE OF THE BAG THAT THE CIRCUIT CAME IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20795823 ↗MalfunctionNov 25, 2024
THERE IS CONDENSATION VISIBLE INSIDE THE BLUE PLASTIC FILTER CONTAINING PIECE OF A SINGLE USE ADULT ANESTHESIA BREATHING CIRCUIT. THE PACKAGE WAS NOT YET OPEN BUT YOU CAN SEE WATER DROPLETS/CONDENSATION ON THE BLUE PIECE INSIDE OF THE BAG THAT THE CIRCUIT CAME IN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20770976 ↗MalfunctionNov 18, 2024
THERE IS CONDENSATION VISIBLE INSIDE THE BLUE PLASTIC FILTER CONTAINING PIECE OF A SINGLE USE ADULT ANESTHESIA BREATHING CIRCUIT. THE PACKAGE WAS NOT YET OPEN BUT YOU CAN SEE WATER DROPLETS/CONDENSATION ON THE BLUE PIECE INSIDE OF THE BAG THAT THE CIRCUIT CAME IN.
Patient problems: Insufficient Information
MAUDE report 20705394 ↗
Other Ventilator, emergency, manual (resuscitator) devices
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- Ventlab AF5140MBPVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall5 reports
- Ventlab AF2140MBPVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall2 reports
- Ventlab AF5142MBPVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall2 reports
- Ventlab SS3200MB-MMCVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
- Ventlab AF2142MC-3Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
- Ventlab AF1140MB-PVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
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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