Crosstex International GPRN95Recalls & reported problems
Crosstex International, Inc. · Isolator Plus N95 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 10732224000524), received between Mar 17, 2023 and Mar 17, 2023 — classified as 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Abrasion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT STUDENTS OBTAINED CUTS ON THEIR NOSES WHILE WEARING ISOLATOR PLUS N95 SURGICAL RESPIRATORS. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Abrasion
MAUDE report 16563966 ↗
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
- Regard™ N95SRGRESP-REGResource Optimization & Innovation, L.L.C. · 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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