Halyard 62408Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20680651624080), received between Jan 8, 2025 and Dec 30, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Component Incompatible” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Component Incompatible; Component Incompatible

  MASKS CONTAINED A YELLOW PLASTIC LINER ON THE INSIDE WHICH MADE IT DIFFICULT FOR SOME TEAM MEMBERS TO BREATHE AFTER A FEW MINUTES. COUNTRY HAS HIGH HUMIDITY. SEVERAL MISSION TEAM MEMBERS REPORTED DIFFICULTIES BREATHING WHILE WEARING THE MASKS. SOME EXPERIENCED PANIC ATTACKS AND HAD TO LEAVE RED ZONE QUICKLY, WITHOUT FOLLOWING FULL EBOLA PROCEDURES. TEAM WAS WORKING IN EBOLA TREATMENT CENTER ON MISSION. ADDITIONAL INFORMATION FROM REPORTER IS PENDING.

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

  MAUDE report 23928782 ↗
• InjuryDec 30, 2025Component Incompatible; Component Incompatible

  MASKS CONTAINED A YELLOW PLASTIC LINER ON THE INSIDE WHICH MADE IT DIFFICULT FOR SOME TEAM MEMBERS TO BREATHE AFTER A FEW MINUTES. COUNTRY HAS HIGH HUMIDITY. SEVERAL MISSION TEAM MEMBERS REPORTED DIFFICULTIES BREATHING WHILE WEARING THE MASKS. SOME EXPERIENCED PANIC ATTACKS AND HAD TO LEAVE RED ZONE QUICKLY, WITHOUT FOLLOWING FULL EBOLA PROCEDURES. TEAM WAS WORKING IN EBOLA TREATMENT CENTER ON MISSION. ADDITIONAL INFORMATION FROM REPORTER IS PENDING.

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

  MAUDE report 23926263 ↗
• MalfunctionJan 8, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  THE CLINICIAN REPORTED THAT A MEMBER OF THE NURSING STAFF WAS WEARING A MASK IN A QUARANTINE AREA FOR CONTAGIOUS DISEASES (COVID). THE BLUE ELASTIC BAND HOLDING THE MASK TO THE WEARER'S FACE SUDDENLY BROKE. THE NURSING STAFF LEFT THE TREATMENT AREA TO RE-MASK.

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

  MAUDE report 21104156 ↗