Halyard 34148Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20680651341482), received between Jun 6, 2023 and Mar 7, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination 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. 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.

• MalfunctionMar 7, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CUSTOMER STATED THAT WHILE WRAPPING A TRAY FOR STERILIZATION, SHE FOUND METAL SHAVINGS IN THE STERILIZATION WRAP. A METAL SHAVING POKED HER AND BROKE THE SKIN ON HER FINGER. THE CUSTOMER WAS NOT ABLE TO LOCATE THE METAL SHAVING FOR EVALUATION. A SECONDARY ISSUE FOR STERILIZATION WRAP WAS COMMUNICATED, THE DAISY PATTERN WAS RAISED AND THERE WAS LINTING OBSERVED. THIS CAUSED A TWO-HOUR DELAY. NO CASES WERE CANCELED. THE CUSTOMER STATED THEY RESOLVED THE ISSUE BY OPENING NEW TRAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21548112 ↗
• InjuryFeb 23, 2024Material Puncture/Hole; Material Puncture/Hole

  CUSTOMER REPORTED SEVERAL WRAPS HAD PIN HOLES IN THEM. THE HOLES CAUSED A DELAY IN PROCEDURE AND REPROCESSING OF PROCEDURE TRAYS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER ON FEBRUARY 15, 2024. NO INSTRUMENTS WERE USED. THE HOLES WERE CAUGHT BEFORE THE CASES WERE STARTED. DELAYS VARIED. SOME OF THEM WE HAD BACKUP INSTRUMENTS AVAILABLE AND DID NOT CAUSE A DELAY IN THE CASE. WE DID NOT KEEP RECORD OF THE DELAYS ON OUR END. I KNOW OUR STAFF WAS ENCOURAGED TO WRITE UORS IF THERE WERE SIGNIFICANT DELAYS TO PATIENT CARE. WE CANNOT GIVE AN EXACT NUMBER OF PROCEDURES OR THE DATES THAT THIS OCCURRED, ALL WE DID WAS REPORT THE INCIDENCES AS THEY WERE OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773011 ↗
• InjuryJun 6, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER STATED, THEY HAD A DELAY IN SURGERY DUE TO TEARS IN THE WRAP (DURING USE WITH PATIENTS IN THE OPERATING ROOM). 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 17076048 ↗