Halyard 69600Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20680651696001), received between Mar 13, 2024 and Jul 11, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Component Incompatible” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2024Component Incompatible; Component Incompatible

  THE CUSTOMER REPORTED STRIKE THROUGH IN THE MIDDLE OF THE GOWN. THE GOWNS WERE USED FOR DECONTAMINATION, NOT FOR USE IN PATIENT CARE FOR THIS INCIDENT. AN EMPLOYEE HAD STRIKE THROUGH WHERE THE DETERGENT CAUSED A REACTION OF BURNING AND IRRITATION. EMPLOYEE WENT TO EMERGENCY DEPARTMENT AND WAS OUT OF WORK FOR 2 DAYS. EMPLOYEE UTILIZED AN OTC CREAM FOR IRRITATION.

  Patient problems: Local Reaction

  MAUDE report 19726607 ↗
• InjuryMar 13, 2024Leak/Splash; Leak/Splash

  CUSTOMER IS DISSATISFIED WITH GOWN PERFORMANCE. CUSTOMER STATES THEY HAVE USED GOWN FOR 15 YEARS AND QUALITY HAS DECREASED. CUSTOMER STATES THE GOWN BECOMES WET WHEN SHE LEANS AGAINST SINK. THE CUSTOMER REPORTED IN 2018 A CO-WORKER EXPERIENCED CHEMICAL BURNS ON THEIR ARMS DURING USE OF THE GOWN WHEN ENZYMATIC FLUID SOAKED THROUGH THE GOWN. THE CO-WORKER WENT TO THE PHYSICIAN MULTIPLE TIMES FOR TREATMENT. THE EXACT EVENT DATE AND FURTHER DETAILS ARE UNKNOWN. THERE WAS NO HOSPITAL STAY OR SURGICAL INTERVENTION PERFORMED.

  Patient problems: Burn(s)

  MAUDE report 18895839 ↗