Regard™ N95SRGRESP-REGRecalls & reported problems
Resource Optimization & Innovation, L.L.C. · N95 RESP SURG LVL 3 FLUID RESIST STD FLAT FOLD WHT 84A-9745 NS LF DISP · Class 2
Data updated Oct 16, 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 10326053123457), received between May 7, 2026 and May 7, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2026Use of Device Problem
THE CUSTOMER REPORTED THAT TEAM MEMBERS AND PROVIDERS ARE CONCERNED WITH THE PRODUCT QUALITY STATING THAT IT IS FLIMSY AND DOES NOT SEAL TO THEIR FACE APPROPRIATELY DUE TO STRAP DESIGN. STAFF ALSO RAISED CONCERN THAT THEY WERE NOT FIT TESTED FOR THE MASK PRIOR TO DONNING AND USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25115688 ↗
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
- KIMBERLY-CLARK® FLUIDSHIELD™ PFR95™ Respirator and Surgical Mask 46767Kimberly-Clark Global Sales, LLC · Respirator,surgical1 report
- Halyard 76727O&M Halyard, Inc. · Respirator, surgical1 report
- Medline NON27501Medline Industries, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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