Halyard 49235Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20680651492351), received between Jul 12, 2019 and Nov 8, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Compatibility 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.

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.

• MalfunctionNov 8, 2021Compatibility Problem; Compatibility Problem

  IT WAS REPORTED BY THE SURGEON WAS USING THE AGREED UPON GREEN MASK FROM HALYARD TODAY AND HIS LOUPES KEPT FOGGING UP. THIS IS A CRITICAL SAFETY ISSUE AS BEING IN THE MIDDLE OF A PROCEDURE AND NOT BEING ABLE TO SEE COULD BE CATASTROPHIC TO THE PATIENT. I KNOW THAT WE SEEM TO HAVE ADAPTED TO THE HALYARD MASK, BUT I AM NOW HEARING THAT THERE HAVE BEEN ISSUES. THE ONES WITH THE PLASTIC ON THE OUTSIDE TEND TO ACCUMULATE MOISTURE FROM THE REBREATHING AND THIS DEVELOPS TO THE POINT THAT IT DRIPS ONTO THE FIELD. THIS RESIDUE CAUSES BREAKOUTS AND RASHES ON STAFF.

  Patient problems: Local Reaction

  MAUDE report 12774785 ↗
• InjuryJul 12, 2019Component Incompatible; Component Incompatible

  DURING A RETROSPECTIVE REVIEW WITH THE FDA ESG HELP DESK IT WAS DETERMINED THAT THIS COMPLAINT WAS SENT TO THE TEST REGION AND NOT THE FDA PRODUCTION REGION; THEREFORE, THIS COMPLAINT IS BEING SUBMITTED TO THE PRODUCTION REGION ON (B)(6) 2019. IT WAS ALLEGE BY A DOCTOR THAT THE ANTI-FOG GREEN SURGICAL MASKS ARE PRONE TO CONDENSATION AND DROPS INTO THE SURGICAL SITE. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8787301 ↗