MEDLINE DYNJAAMASK35Recalls & reported problems
Medline Industries, Inc. · MASK,FLEXIBLE,ANESTH,SIZE 5,TOP VALVE · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277399310), received between Sep 23, 2026 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Deformation2
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.
MalfunctionSep 30, 2026Material Deformation
It was reported that: "Deformed mask shape. See image below comparing the normal (oval) to the abnormal (rounded)."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946326 ↗MalfunctionSep 23, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50874574 ↗
Other MASK, GAS, ANESTHETIC devices
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- Ventlab BT2048Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4018Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4013Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4019Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4022Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4015Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
- Ventlab BT4024Ventlab, LLC · Mask, Gas, Anesthetic1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.