KIMBERLY-CLARK® FLUIDSHIELD™ PFR95™ Respirator and Surgical Mask 46727Recalls & reported problems
Kimberly-Clark Global Sales, LLC · N95 Particulate Filter Respirator and Surgical Mask · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00036000467277), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Fell” (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.
Most reported problems
Device problems
- Device Fell1
- Material Too Soft/Flexible1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 16, 2021Material Too Soft/Flexible; Device Fell
NURSING STAFF REPORT DURING DONNING KIMBERLY CLARK N95 DUCKBILL REGULAR SIZE MASK THE RUBBER BAND DIDN'T HOLD IT'S ELASTICITY CAUSING THE MASK TO FALL FROM THEIR FACE. THIS INCIDENT WAS ABLE TO BE REPEATED WITH FIVE MASKS FROM TWO DIFFERENT BOXES.
Patient problems: Insufficient Information
MAUDE report 12819415 ↗
Other Respirator,surgical devices
- Halyard 46827O&M Halyard, Inc. · Respirator, Surgical1 recall33 reports
- Halyard 46727O&M Halyard, Inc. · Respirator, Surgical24 reports
- Halyard 46767O&M Halyard, Inc. · Respirator, Surgical6 reports
- Halyard 46867O&M Halyard, Inc. · Respirator, Surgical6 reports
- Moldex 1512 N95Moldex-Metric, Inc. · Respirator,Surgical2 reports
- Aura™ 1870+3M Company · Respirator,surgical1 report
- KIMBERLY-CLARK® FLUIDSHIELD™ PFR95™ Respirator and Surgical Mask 46767Kimberly-Clark Global Sales, LLC · Respirator,surgical1 report
- Crosstex International GPRN95Crosstex International, Inc. · Respirator,surgical1 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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