Medline NON27410Recalls & reported problems
Medline Industries, Inc. · MASK,FACE,FLUID RES,SHLD,FOGFREE,TIES · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10080196713943), received between Jul 10, 2026 and Sep 28, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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. 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
- Loss of or Failure to Bond5
- Material Fragmentation4
- Detachment of Device or Device Component2
- Incomplete or Inadequate Connection1
- Material Separation1
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions14
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921676 ↗MalfunctionSep 11, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739844 ↗MalfunctionSep 11, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50739843 ↗MalfunctionAug 27, 2026Detachment of Device or Device Component
It was reported that "operating room face masks with the shield are defective. Have been having problems with the face shield portion falling off mid-case."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50485627 ↗MalfunctionAug 14, 2026Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50263427 ↗MalfunctionAug 14, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50261976 ↗MalfunctionAug 6, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50165027 ↗MalfunctionAug 5, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140738 ↗MalfunctionJul 31, 2026Incomplete or Inadequate Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105087 ↗MalfunctionJul 28, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060258 ↗MalfunctionJul 28, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060251 ↗MalfunctionJul 21, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25899693 ↗MalfunctionJul 21, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25899692 ↗MalfunctionJul 10, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25788645 ↗
Other Mask, surgical devices
- Halyard 47117O&M Halyard, Inc. · Mask, surgical1 recall12 reports
- Halyard 47147O&M Halyard, Inc. · Mask, surgical1 recall1 report
- Henry Schein 5702448Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Criterion 5703281Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Halyard 47500O&M Halyard, Inc. · Mask, surgical1 recall0 reports
- UltraTM Earloop Mask GCFCXSCrosstex International, Inc. · Mask, surgical8 reports
- UltraTM Sensitive FogFreeTM Earloop Mask w/ Secure FitTM GCFCXSSFCrosstex International, Inc. · Mask, surgical5 reports
- CONVERTORS AT70021Cardinal Health 200, LLC · Mask, surgical5 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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