Halyard 44673Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651446739), received between Mar 1, 2023 and Mar 5, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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.

• InjuryMar 5, 2024Material Integrity Problem; Material Integrity Problem

  THE CUSTOMER REPORTED THAT SEVERAL STAFF MEMBERS, INCLUDING SURGEONS WERE EXPERIENCING ISSUES WITH SKIN BREAKDOWN AROUND THEIR WRIST AND LOWER FOREARM. THE STAFF FEELS THE ISSUE IS BEING CAUSED BY SOMETHING IN THE CUFF OF THE GOWNS. PER CUSTOMER, STAFF MEMBER(S) HAD TO SCHEDULE APPOINTMENT WITH DERMATOLOGIST AND WAS PRESCRIBED STEROID RX. THERE WAS NO LOSS OF WORK TIME AS A RESULT. CUSTOMER PROVIDED SAMPLE FOR EVALUATION FROM THE CURRENT INVENTORY; HOWEVER, THEY INDICATED THEY DO NOT KNOW THE COMPLAINT LOT(S).

  Patient problems: Local Reaction

  MAUDE report 18842692 ↗
• MalfunctionMar 1, 2023Contamination

  INSECT FOUND INSIDE THE STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16459769 ↗