Ventlab SS3200MB-MMCRecalls & reported problems
Ventlab, LLC · INFANT SAFE SPOT W/MANOMETER, MASK,BAG RESERVOIR AND STICKER · Class 2
Data updated Oct 13, 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483105771), received between Apr 11, 2026 and Apr 11, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
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. How this data works · Data updated Oct 13, 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-0365-2024 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Material Integrity Problem1
Patient problems
- Low Oxygen Saturation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2026Material Integrity Problem
IT WAS REORTED THAT WHEN STAFF OPENED THE PACKAGING FOR PEDIATRIC BVM THE AMBU BAG MALFUNCTIONED- VALVE BROKE OFF. REPORTS PEDIATRIC PATIENT WAS IN RESPIRATORY DISTRESS. WHEN STAFF OPENED THE PACKAGING FOR PEDIATRIC BVM THE AMBU BAG MALFUNCTIONED- VALVE BROKE OFF, RESULTING IN INABILITY TO VENTILATE PATIENT. USED A LARGER PRODUCT AND PATIENT MAINTAINED PATIENT SAFETY.
Patient problems: Low Oxygen Saturation
MAUDE report 24851037 ↗
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 AF5142MBPVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall2 reports
- Ventlab AF2140MBPVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall2 reports
- Ventlab AF1140MBVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 report
- Ventlab AF2142MBVentlab, LLC · Ventilator, Emergency, Manual (Resuscitator)1 recall1 death1 report
- Ventlab VN3100OBVentlab, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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