Halyard 34147Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20680651341475), received between Feb 16, 2024 and Jan 27, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).

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.

• MalfunctionJan 27, 2026

  FLAKING WAS DISCOVERED ON THE SIZE LABELING WITHIN THE WRAP. THE TECHNICIAN PLACED A PIECE OF TAPE OVER THE LABELING, AND BLACK FLAKES FROM THE PRINTING CAME OFF WITH THE TAPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188013 ↗
• InjuryJun 13, 2024Material Puncture/Hole; Material Puncture/Hole

  HOLES WERE FOUND IN THE STERILIZATION WRAP AT THE TIME OF OR SET UP. ITEMS HAD TO BE SENT BACK TO CSR TO BE REPROCESSED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REQUIRED FOR PATIENT(S). THERE WAS A DELAY IN CASES, IN SOME INSTANCES, THE DELAY WAS AN HOUR OR LONGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19530263 ↗
• InjuryFeb 16, 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 INCIDENT QUESTIONS WERE ASKED OF THE CUSTOMER ON 01/19/24, 01/26/24, AND 01/30/24. NO RESPONSE HAS BEEN PROVIDED TO-DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18727059 ↗