Moldex 1512 N95Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00092311151205), received between Dec 17, 2020 and Dec 18, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  COUGHING, SNEEZING, RUNNY NOSE, RED RASH LIKE REACTION AROUND FACE.

  Patient problems: Cough; Rash

  MAUDE report 11037942 ↗
• InjuryDec 17, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  CRNA USING REPROCESSED MASK FROM (B)(6). BECAME SHORT OF BREATH AND UNABLE TO BREATHE WHEN WEARING REPROCESSED MASK. NEW MASK GIVEN, NO FURTHER PROBLEMS REPORTED. FDA SAFETY REPORT ID#(B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11033147 ↗