Ventlab AF5142MBPRecalls & reported problems
Ventlab, LLC · AirFlow Adult Resuscitator with Integrated Manometer, B/V Filter, 40cm Pop-Off, Bag Reservoir, Mask, and PEEP Valve · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889483091838), received between Dec 23, 2025 and Dec 23, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name this device's 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, 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 16, 2026.
Reports received per month
Recalls naming this device
- Oct 11, 2023Open, Classified
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
Z-0361-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 23, 2025Break; Break
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED XX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING XX DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 1314417-2025-00112 FOR THE FIRST REPORT. IT WAS REPORTED, THE SAFETY POP OFF VALVE BROKE. THERE WAS NO REPORT OF A DELAY IN THERAPY, HURT, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877950 ↗MalfunctionDec 23, 2025Break; Break
SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 1314417-2025-00113 FOR THE SECOND REPORT IT WAS REPORTED, THE SAFETY POP OFF VALVE BROKE. THERE WAS NO REPORT OF A DELAY IN THERAPY, HURT, HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23877942 ↗
Other Ventilator, Emergency, Manual (Resuscitator) devices
- Ventlab AF5140MBVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall8 reports
- Curaplex AF2000Bound Tree Medical, LLC · Ventilator, emergency, manual (resuscitator)1 recall6 reports
- Ventlab AF5140MBPVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall5 reports
- Ventlab AF2140MBPVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall2 reports
- Ventlab AF2142MC-3Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
- Ventlab SS3200MB-MMCVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
- Medline CPRM1126FPWMMedline Industries, Inc. · Ventilator, emergency, manual (resuscitator)1 recall1 report
- Medline CPRM1116FMMedline Industries, Inc. · 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 · each recall links to the FDA recall notice
- 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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