Halyard 34199Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20680651341994), received between May 23, 2023 and Aug 14, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 14, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261013 ↗
• InjuryJun 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER STATED, THEY HAD A DELAY OF CASES DUE TO TEARS IN THE WRAP (DURING USE WITH PATIENTS IN THE OR). THIS WAS RESOLVED BY REPLACING THE TRAYS. IN ONE INSTANCE THE TRAY WAS ONE OF A KIND AND THEY HAD TO WAIT AN HOUR AND A HALF FOR STERILE PROCESSING TO REPLACE THE TRAY. NO INJURY WAS REPORTED TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT HAD TO BE WOKEN UP FROM ANESTHESIA. NO INSTRUMENTS FROM THE TRAYS WERE REPORTED AS USED ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17101615 ↗
• InjuryMay 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INCIDENT TWO. CUSTOMER REPORTED THEY HAVE EXPERIENCED WET PACKS. THIS RESULTED IN PATIENT DELAY IN PROCEDURE. ADDITIONAL INCIDENT DETAILS HAVE BEEN REQUESTED.

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

  MAUDE report 16988869 ↗