Halyard 41734Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10680651417340), received between Sep 4, 2024 and Feb 6, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Accessory Incompatible” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 31, 2022Open, Classified

   Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection

   Z-0343-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 6, 2025Accessory Incompatible; Accessory Incompatible

  INCIDENT ONE STAFF MEMBER REPORTED THEY DEVELOPED RASH ON FOREARMS, HANDS, AND INNER ELBOW AREAS. STAFF MEMBER HAD WORN THE SAME GOWN PRODUCT 1-2 MONTHS BEFORE REACTION WAS NOTED. THE REACTION ONLY OCCURRED WHERE THE GOWN HAD DIRECT CONTACT WITH THE SKIN. STAFF MEMBER DENIED ANY CHANGES IN SOAPS, HAND SANITIZERS, LOTION, OR LAUNDRY DETERGENT. STAFF MEMBER RECEIVED TREATMENT FROM EMPLOYEE HEALTH, TRIAMCINOLONE STEROID CREAM WAS PRESCRIBED. RASH RESOLVED WITH TOPICAL MEDICATION AND SWITCHING TO ALTERNATE GOWN PRODUCT.

  Patient problems: Local Reaction

  MAUDE report 21329673 ↗
• InjuryFeb 6, 2025Accessory Incompatible; Accessory Incompatible

  INCIDENT TWO: EMPLOYEE REPORTED RASH ON FOREARMS, HANDS, AND INNER ELBOW AREAS AFTER WEARING HALYARD GOWN FOR 1-2 MONTHS. EMPLOYEE DENIED ANY CHANGES IN SOAPS, HAND SANITIZERS, LOTION, OR LAUNDRY DETERGENTS. EMPLOYEE WAS SEEN BY THEIR PRIMARY CARE PHYSICIAN. THEIR PHYSICIAN PRESCRIBED TRIAMCINOLONE STEROID CREAM. ISSUE WAS RESOLVED BY TOPICAL MEDICATION AND SWITCHING TO ALTERNATIVE GOWN WITHOUT FURTHER INCIDENT. NO LOT NUMBER PROVIDED AS MOST OF THE GOWNS WERE DISPOSED OF.

  Patient problems: Local Reaction

  MAUDE report 21329025 ↗
• InjuryFeb 6, 2025Accessory Incompatible; Accessory Incompatible

  INCIDENT THREE AN EMPLOYEE WAS REPORTED TO HAVE AN ISSUE WITH WEARING HALYARD GOWN SINCE JULY 2024. THE EMPLOYEE DEVELOPED A RASH ON FOREARMS, HANDS AND INNER ELBOW AREA. THE EMPLOYEE HAS BEEN SEEN BY EMPLOYEE HEALTH MULTIPLE TIMES WHERE THEY WERE PROVIDED TOPICAL MEDICATION AND ADVISED TO WEAR ALTERNATE GOWN.

  Patient problems: Local Reaction

  MAUDE report 21329023 ↗
• InjuryOct 30, 2024Component Incompatible; Component Incompatible

  A STRONG CHEMICAL SMELL WAS REPORTED BY THE CUSTOMER COMING FROM THE HALYARD AERO BLUE PERFORMANCE SURGICAL GOWN, XL. ONE STAFF MEMBER REQUIRED MEDICAL EVALUATION; TREATMENT DETAILS REMAIN UNKNOWN. THE SMELL APPEARS TO BE LIMITED TO THE GOWN AND LOT. THE ENTIRE LOT ASSOCIATED WITH THIS GOWN HAS BEEN QUARANTINED BY THE CUSTOMER. ON (B)(6) 2024, A RESPONSE WAS RECEIVED FROM THE CUSTOMER THAT STATES THERE WAS NO DELAY IN SURGICAL OR EMERGENCY PROCEDURES. THE PRODUCT WAS SHIPPED TO (B)(6) CLINIC BY A DISTRIBUTOR.

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

  MAUDE report 20567440 ↗
• MalfunctionSep 4, 2024Product Quality Problem; Product Quality Problem

  THE STAFF WAS PREPARING TO SETUP A ROOM FOR SURGERY AND NOTICED A STRONG SMELL. THE OR HAD TO BE SHUT DOWN DUE TO THE SMELL AS THE FACILITY WAS UNSURE WHERE THE SMELL WAS COMING FROM. STAFF MEMBER(S) BECAME ILL FROM THE SMELL. THE FACILITY MENTIONED THEY HAVE A DEVICE THAT COULD BE USED TO DETERMINE THE PARAMETER OF GAS OR EO AND THE DEVICE HAD NO INDICATION THAT THE OR WAS COMPROMISED BY SUCH CHEMICALS. THE CLINICIAN DETERMINED THE SMELL WAS NOT COMING FROM ANESTHESIA AND LATER ALLEGED THE SMELL WAS COMING FROM THE AEROBLUE GOWN. ADDITIONAL DETAILS REGARDING STAFF MEMBER MEDICAL INTERVENTION AND STATUS WERE REQUESTED, THE CUSTOMER RESPONDENT INDICATED THESE DETAILS WERE UNKNOWN.

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

  MAUDE report 20140621 ↗