Halyard 41733Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651417333), received between Sep 4, 2024 and Sep 4, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Product Quality 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Product Quality Problem; Product Quality Problem

  THE STAFF WAS PREPARING TO SETUP A ROOM FOR SURGERY AND NOTICED A STRONG SMELL. THE OR HAD TO BE SHUT DOWN DUE TO THE SMELL AS THE FACILITY WAS UNSURE WHERE THE SMELL WAS COMING FROM. STAFF MEMBER(S) BECAME ILL FROM THE SMELL. THE FACILITY MENTIONED THEY HAVE A DEVICE THAT COULD BE USED TO DETERMINE THE PARAMETER OF GAS OR EO AND THE DEVICE HAD NO INDICATION THAT THE OR WAS COMPROMISED BY SUCH CHEMICALS. THE CLINICIAN DETERMINED THE SMELL WAS NOT COMING FROM ANESTHESIA AND LATER ALLEGED THE SMELL WAS COMING FROM THE AEROBLUE GOWN. ADDITIONAL DETAILS REGARDING STAFF MEMBER MEDICAL INTERVENTION AND STATUS WERE REQUESTED, THE CUSTOMER RESPONDENT INDICATED THESE DETAILS WERE UNKNOWN.

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

  MAUDE report 20140657 ↗