Halyard 44674Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651446746), received between Sep 13, 2023 and May 20, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Compatibility 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 16, 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.

• MalfunctionMay 20, 2024

  WHEN UNFOLDING AND OPENING THE STERILE GOWN A PIECE OF BLUE STICKY TAPE WAS FOUND INSIDE THE STERILE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350722 ↗
• 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. THE CUSTOMER DOES NOT KNOW THE LOT NUMBER FOR THE PRODUCT REPORTED. THE CUSTOMER DID RETURN SAMPLE FROM CURRENT INVENTORY.

  Patient problems: Local Reaction

  MAUDE report 18839467 ↗
• InjurySep 13, 2023Compatibility Problem; Compatibility Problem

  DERMATOLOGIST REPORTS THAT HIS PATIENT HAS A SUSPECTED ALLERGY TO AN INGREDIENT IN SLEEVE AND COLLAR PORTION OF SURGICAL GOWNS. THE PATIENT UTILIZES AERO BLUE PERFORMANCE SURGICAL GOWN (REF # (B)(4)) AND THE AERO CHROME BREATHABLE PERFORMANCE SURGICAL GOWN (REF # (B)(4)). PATIENT HAS A HISTORY OF ALLERGIC CONTACT DERMATITIS TO SEVERAL ALLERGENS, INCLUDING CARBA MIX IN SURGICAL GLOVES. PATIENT PRESENTS WITH RASH ON HANDS AND CENTRAL NECK, THAT WORSENS AFTER SURGICAL DAYS. THESE AREAS ARE TOUCHED BY THE CUFF AND NECKLINE OF THE SURGICAL GOWNS. PATIENT RECEIVES TOPICAL PRESCRIPTION STEROIDS AND OTHER TEATMENTS NOT SPECIFIED.

  Patient problems: Rash

  MAUDE report 17736688 ↗